Figueroa Indictment

KS
Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 1 of 21
Mar 1, 2022
IN TH E UN ITED STA TES D ISTRIC T CO UR T
FO R SO U TH ER N D ISTR ICT O F FL O RID A
C A SE N O .22-60033-CR-COHN/STRAUSS
18U.S.C.j371
18U.S.C.jj1505 and2
18U.S.C.jj1519 and2
21U.S.C.jj331(a)and 333(a)(1)
UM TED STATES OF AM ERICA
VS.
R M D EL FIG U ER O A ,
a/k/a dilèey Figueroar''
a/k/a çdlèay Figueroa,''
D efendant.
/
IN DIC TM EN T
The Grand Jury chargesthat:
G EN ER AL A LLEG A TIO N S
Ata11tim esm aterialto thisIndictm ent'

.
R elevant Corporate Entities
1. Phnrmatech,LLC (Kûphnrmatech'')wasan activeFloridacorporation,which was

incorporated on oraboutN ovem berof2009,and located in Brow ard Cotmty,Florida.Phnrm atech
m anufactured drugsand dietary supplem entsfordistlibutors.
CardinalHea1thwasadistlibutorofphnrm aceuticalsand am armfacturerofm edical
and laboratoryproducts. CardinalHealth om wd TheHarvardDnlg Group.
3. The H arvard D rug Group,am ong other things,w as a distributor of drugs. The
H arvard D rug Group w as Phnrm atech's custom er. The H arvard Dnzg Group received a liquid
product called Gr iocto Liquid,''tmder the nnme Ellkugbyy''which Phnrmatech manufactured,

packaged,and labeled forTheHarvard Dnzg Group.
OfcusPhnrma,Inc.(GçofcusPhnrma'')wasaFloridacorporation,incorporated on
oraboutOctober20,2016,andlocatedinBroward County,Florida.OfcusPhnrmawasestablished
forthepup oseofm anufacm ring oralsolid drugsand dietary supplem ents.
The D efendant
From atleaston or aboutM arch 2016 through September2017,the defendant,

.
R AID EL FIG UER O A , w as a co-ow ner of Pharm atech, and the Chief Executive Ofd cer of
Pharm atech. Dllringthistim e,RAIDEL FIGUEROA representedtotheUnited StatesFood and
DnlgAdministration(G1FDA'')thathehadtheduty,responsibility,andauthorityforenstuingthat
Phnrmatech'sproductscomplied with a1lrelevantlaws,including the FederalFood,Dnlg,and
Cosm eticAct.Hefurtherrepresentedthathehad theresponsibility forpreventing,detecting,and
correcting any violations ofthose law s atPhnrm atech.
6. From on or about October 20,2016 through on or about December 15,2016,
RAIDEL FIGUEROA waslisted in cop oratefilingswith the StateofFloridaasthepresidentof
O fcus Pharm a. O n or about D ecem ber 15, 2016, R AIDEL FIG U ER O A w as rem oved as
Presidentand TreastlrerofOfcusPhnrma,and on oraboutDecember 20,2016,lndividualOne
wasadded asthePresidentand TreasurerofOfcusPhnrma in cop orate filingswith the State of
Florida.Despitethesefilings,from on oraboutOctober20,2016through October2017,RAIDEL
FIG U ER O A rem ained the owner of Ofcus Pharma and ultim ately controlled the operations of
OfcusPhnrm a.
The U nited States Food and D rue A dm inistration
The FDA was a federalagency ofthe United StatesD epartm entofHea1th and
Hllman Selwices,which was responsible for protecth g the health and safety of the public by
enforcing theFederalFood,Drug,and CosmeticAct(lltheFDCA''),21U.S.C.j301etseq. In

implementing and enforcingtheFDCA,theFDA'Slawftzlftmctionsincluded,am ong otherthings,
regulating the manufactureand distribution ofdrugsand dietary supplements,enstzring thatdrtzgs
were safe and effective for their intended uses,inspecting facilities where drugs and dietary
supplem ents were manufactured,processed,packed,and held,and investigating outbreaks of
irlfectionsrelated to potentially contnm inated drugs.
8. The FDCA defined a Gtdrug''in relevantpart,as an article intended foruse in the
diagnosis,clzre,m itigation,treatment,orprevention ofdisease in man or othernnimals,and an
article(otherthanfood)intendedtoaffectthestructureoranyfunctionofthebody ofmanorother
arlimals.21U.S.C.j321(g)(1)(B)and (C).
9. ItwasillegaltmdertheFDCA tointroduceordeliverforintroduction intointerstate
com m erce or cause the introduction or delivery for introduction into interstate com m erce, an
adulterateddrtzg.21U.S.C.j331(a).
10. UndertheFDCA,adrug wasdeem edto beEûadulterated''if,nm ong otherthings:
it consisted in whole or in part of any filthy, putl'id or decomposed
substance,21U.S.C.5351(a)(1);or
itw asprepared,packed,orheld tm derinsanitary conditionsw hereby itm ay
have been contam inated with /1th, or whereby it m ay have been rendered
injtlrioustohealth,21U.S.C.j351(a)(2)(A).
11. Under the FDCA,the FDA had the authority to enter,atreasonable tim es,any
factory,warehouse,orestablishm entin which drugsordietary supplem entswerem anufactured,
processed,packed,orheld,for introduction into interstate com merce oraftersuch introduction,
andto inspect,atreasonabletim esand witllin reasonable lim itsand in areasonablem nnner,such
factoly, warehouse, or establishm ent and all pertinent equipm ent, finished and unfizlished
m aterials,containers,and labeling therein.In thecaseofatly factory,warehouse,establishm ent,
orconsulting laboratory in wllich prescription dnzgsornonprescription drugs intended forhllm an
usewerem anufactured,processed,packed,orheld,theauthority to inspectextended to a1lthings
therein (including records,files,papers,processes,controlsand facilities)beadng on whether

prescription dnlgs or nonprescription drugs intended for hllman use have been or were being
manufacttlred,processed,packed,transported,orheld i,
n any such place,orotherwisebearing on
aviolation oftheFDCA.21U.S.C.j374(a)(1).
Plzrsuantto theFDCA,asdescribed in paragraph 11,the FDA had theauthority to
enter and inspect Phnrmatech, Ofcus Phnrma, and any other dnzg or dietat'y supplement
m anufacturing facility R M DEL FIG UER O A owned orcontrolled.
D iocto Liquid
From at least 2016 through at least M arch 2017,Phnrm atech m anufactlzred a
productcalled Gr iocto Liquid''forThe Halward Dnzg Group tmderthe nnme GlRugby.'' Diocto
Liquid was a docusate sodillm liquid solution used to treatconstipation in adults and children.
Docusate sodium was the generic nnm e for the product,and tr iocto Liquid''was the nnm e
Phnrm atech used to labelthe docusate sodium liquid solution it m anufactured for The H arvazd
D nlg Group.
14. DioctoLiquidwasaççdrtzg''withinthemeatlingof21U.S.C.j321(g)(1).
TheBacteriaBurltholderia cepacia (B.cepaciaj
15. Burkholderia cepacia($T.cepacia'')wasthenamefotagroup orGlcomplex''of

bacteria typically fotm d in soil and w ater.These bacteria poséd little m edicalrisk to healthy
people,butpeople w ho had certain health problem s like w eakened im m une system s orcllronic
ltmg diseasesm ay havebeen m oresusceptibletoB.cepacia infections.TheeffectsofB.cepacia
could include sedous respiratory infections and other types of irlfections. Contnm inated
m edicinescouldtransm itB.cepacia,andthebacteriawereoftenresistanttocom m on antibiotics.
FD A Inspection ofPharm atech in July - A ugust2016 and Pharm atech's

R ecallofO ralLiquid Products,lncluding D iocto Liquid,
Due to the PotentialR isk ofProductC ontam ination Involvinz B .cepacia
16. On oraboutJuly 5,2016,FDA regulatory investigators(CTDA investigators'')

initiatedaninspectionofPhnnnatech(:tluly-August2016FDA'lnspection').
17. FDA initiated the for-cause inspection atPharmatech aspartof an investigation
into an outbreak ofB.cepacia infectionsand concern thatPharm atech'sDioctoLiquid m ay have
been a potentialsource ofthe infections.
18. D tlring the inspection, R AID EL FIG U ER O A identified him self to the FD A
investigatorsastheco-ownerand CEO ofPhnrmatech.Headmitledthathehadtheduty,authority,
gnd responsibility to prevent, deted, and corred violations, and that all supervisory level
employeesreported tohim .
19. In oraboutJuly 15,2016,Pharmatech voltmtadly recalled al1lutsofPhnrmatech's
Diocto Liquid lGin theinterestofpublic safety afteritwas discovered thatsom e bottlesm ay be
adulterated with Burkholderia cepacia.',
20. ln or about August 5, 2016, Phnrmatech issued a voluntary recall expansion
(GtAugust2016 recall'')to coveradditionalliquid productsGidueto a potentialrisk ofproduct

5
contam ination with Btlrkholderia Cepacia.'' In or about July/August of 2016, Pharm atech
temporarily stoppedm anufacturing liquid products.
21. AtthecloseoftheJuly -August2016 FDA inspection,which occurredon orabout
A ugust 9, 2016, the FD A investigators issued an FD A Form 483 to R M D EL FIG U ER O A
notifying him of multiple inspectionalobservations identifying objectionable conditions at

Phnrm atech.
22. Among other things,the FDA Fonn 483 notified R M DEL FIGUEROA thata
sample of water taken by an FDA investigator from Phnrmatech's water system dllring the
inspection had tested positive forthe presence ofB.cepacia.
In or aboutAugust25,2016,R AIDEL FIG U ER O A provided a wlitten response
to the FD A Form 483 advising ofcorrective actions Phnrm atech w as undertnking,including re-
engineeringitsUSPPudtiedW aterSystem (tGwatersystem'')topreventcontnminationofthewater

used forproduction and cleaning pup oses.
24. In an em aildated O ctober 13,2016,R AIDE L FIG UE R OA advised the FDA that
Pharm atech w as m oving aw ay from the production of solid products and focusing one h'undred
percenton liquid products.Additionally,R M DEL FIG UEROA advised theFDA thatthe Gçlast
Batch issueform anufacturing forliquidswas:07/14/16,and forsolidswas07/20/16.''
25. In a letter dated Janualy 12,2017,R M DEL FIG UER O A advised the FDA that
Pharm atech Gthad ceased all production of solid products, and is now a liquid oral dose
m anufactaring com pany.''
FDA R eeulatorv M eetinz w ith R M D EL FIG U ER O A on Januaa 17.2017
26. On or aboutJanuary 17,2017,the FD A held a regulatory m eeting w ith R ATDE L
FIGUEROA forthepurposesof:(1)givingPharmatechtheopportunitytodiseussthecompany's
present status and f'uttu'e plans; and (2) for Phnrmatech to provide their plans relating to
Phnrmatech's manufactudng practices ofthe drugs and dietary supplem ents itproduced after
Phnrmatech'stwo voltmtary recallsin 2016.
Dtlring the m eeting,R AID EL FIG U ER OA advised the FD A thatPhnrm atech had
addressed Phnrmatech's water issues,and that a one hundred percentnew water system was
installed. H e also advised the FDA that Pharm atech w as focused on several over-the-counter
liquid drugs,w hich included D iocto Liquid.
28. The FDA advised R AIDE L FIG U ER OA thatthe FD A still had concem s about
the distribution ofdrugspriorto an FDA inspection,and thattheFDA'Sconcernscould only be
alleviated by an FD A inspection. The FDA asked R AID EL FIG UER O A to voltm tarily inform
theFDA when Pharmatech started distlibutingproducts.R M DEL FIGUEROA advisedtheFDA
thatPhnrmatech would voltmtarily advisetheFDA when Pharmatech wasready fordistribution.
D istribution ofD iocto Liquid on M arch 7.2017 to The H arvard D ruz G roup - Lot#
20351701
29. O n or aboutM arch 7,2017,Phannatech shipped,interstate,approxim ately 7,308
lmitsofDiocto Liquid,Lot# 20351701,from Floridato TheHarvard Dt'ug Grouptmderthelabel
GGltugby,''ordernum ber&THARM 03072017,''withoutnotifying theFDA and withoutthe FDA'S
lcnowledge.
FD A Inspection ofPharm atech on M arch - M av 2017
On or about M arch 20,2017,FDA investigators initiated another inspection at
Pharmatech (çlM arch -M ay2017FDA Inspection'')tocontinueto collectevidencerelatedtothe

2016 B.cepacia outbreak investigation and evaluate the current and future public health risk
associated with Pharmatech products.
D uring the inspection, R AID EL FIG U ER O A confirm ed that he oversaw al1
operations atthe firm,including the hiring and tiring of employees and thathe had the duty,
authodty,andresponsibilitytoprevent,detectandcorrectviolations.R AIDEL FIGUEROA told
theFDA thathehadbeenactingastheDizectorofQualitysinceM arch2016.

32. During the inspection,RAIDEL FIGUEROA also told FDA investigators that
Phnrmatech hadresum çd m anufacturing in Novem ber2016.
R AID EL FIG U ER O A 'SFailure to disclose to the FD A

thatPharm atech H ad M anufactured and Distributed D iocto Liquid
33. On oraboutM arch 20,2017,FDA investigatorsrequested RAIDEL FIGUEROA
provide a product list of a11 the products Phnrmatech had m anufacttlred aftér it restlmed
m anufactuling.Inresponse,RATDEL FIGUEROA causedaproductlist,whichhethen andthere
wellknew did notincludeDioctoLiquid,to beprovided totheFDA and to befalsely represented
totheFDA asacompletelistofal1theproductsthatwerem anufactured afterPharmatech resllmed
m anufacturing.
34. On oraboutM arch 27,2017,FDA investigatorsdiscoveredthattheproductlistthat
w asprovided to them on oraboutM arch 20,2017,w asincom plete and again requested R AIDEL
FIGIJEROA toprovide a complete listofalltheproductsPhnrmatech had m anufactured afterit
resum ed m anufacturing. In response,R AID EL FIG U ER O A caused a second productlist,which
he then and there w ellknew did notinclude D iocto Liquid,to be provided to the FDA and falsely
represented to the FDA as a com plete list of a11 the products that were m anufactured after
Pharmatech resm ned m mm facturing.

Atnotim ebeforeorduringtheM arch -M ay 2017 FDA Inspection,did R M DEL
FIGUEROA orany otherrepresentativeofPhnrmatech advisetheFDA thaton oraboutM arch 7,
2017,Phnnnatech manufacttzred and distributed DioctoLiquid.
R AID EL FIG U ER O A 'SFalse R epresentation to the FDA thatthatPhase3 Testing of

Pharm atech'sW ater Svstem M etA cceptance C riteria
36. On oraboutApril4,2017,R M DEL FIGEROA caused a mem orandtlm with the
subjectlinetCUSP W aterSystem Timeline,''which hesigned,to beprovidedtotheFDA,which

was Inisleading because itcontained a false statem ent. The m emorandllm falsely stated to the
FDA thatGûA.
softhe dateofthism em o,al1data forPhase 3hasm etacceptmwecriteria,''when in
truth and in fact,and asR ATDEL FIGUEROA then and therewellknew ,a1ldata forPhase 3
testing of Phnrmatech's water system had not m et acceptance criteria because R AIDEL
FIGUEROA knew thatawatersampletaken on February 15,2017 from thewatersystem tested
presumptivepositiveforthepresenceofB.cepacia.
R AID EL FIG U ER O A 'SFailureto D isclose H isO w nership and Controlof

O fcus Pharm a to the FD A
Duzing theM arch -M ay 2017 FDA lnspection,FDA investigatorsrequested that
RAIDEL FIG UEROA identify any otheraffiliated businesseshe owned,even ifthey werenot
registered tmder Vs name,and any other manufacturing locations. In response,RM DEL

FIGUEROA failedto disol6sethatheowned and controlledOfcusPhnrma,wbichwasacompany
established forthepuzposeofm anufactudng oralsolid drugsand dietary supplem ents.
CloseofM arch - M av 2017 FDA Inspedion
Atthe close oftheM arch -M ay 2017 FD A inspection,w hich w ason oraboutM ay
2,2017,FD A investigatorsissued an FDA Form 483 to R AIDE L FIG U ER O A notifying him of
multipleinspectionalobservationsidentifyingobjectionableconditionsatPhnrmatech.
9
39. On oraboutM ay 22,2017,RM DEL FIGUEROA provided awritten responseto
the FDA Form 483 advising the FDA of corrective actions Pharmatech was undertnking.
A dditionally,R AIDEL FIGU ER O A represented thatPharm atech had m adethe decision to cease
allliquid oraldoseproduction tmtilthe item slisted in theForm FDA 483 had been addressed in
1 11. '
'
2017 B.cepacia O utbreak
40. ln oraboutJuly 2017,the CenterforDisease Controland Prevention (<:CDC'')

notified FD A of an investigation into m ultiple cases ofB.cepacia infections irlpediatric patients
atStanfordChildren'sHealthLucilePackardChildren'sHospital,(StanfordCEldren'sHealth)in
Palo Alto,California and atJohnsHopldnsChildren's Center tlohnsHopldns)in Baltimore,
M aryland.
41. TheHarvard Drug Group receivedDiocto LiquidLot#203517019om Phnrmatech
in early 2017. Diocto Liquid Lot #20351701 was vltimately distributed to hospitals and
Phnrmacies,sucltasStanfordChildren'sHea1thandJohnHopldns.
42. On or aboutAugust 1,2017,The H atward Dnzg Group voltmtadly recalled a11
unexpired lots of Phnnnatech's Diocto Liquid due to a risk of product contnm ination w ith B.
cepacia.
43. On oraboutAugust2,2017,FDA investigatorscollected threetmopenedbottesof
Phnnnatech'sDiocto Liquid Lot#20351701 f'

rom Stnnford Cllildren'sHealth in Califonzia. An
FDA laboratory tested thesnm plesand one ofthe gnm plescontained totalaerobicm icrobialcounts
(TAM C) andtotalyeastandmoldcotmts(TYM C)in excessofacceptablelimits.

44. On or aboutAugust3,2017,FD A investigatorscollected eighttm opened botlles of
Pharm atech's D iocto Liquid Lot #20351701 from Johns H opldns in M aryland. An FD A
10
laboratory tested the sam plesand severalofthe snmplescontained TAM C and TYM C in excess
ofacceptable limits.Severalsamples also tested positive for the presence of#.cepacia. FDA
investigators also collected two opened bottlesof Phnrmatech'sDiocto Liquid Lot//20351701
from Johns Hopldns in M aryland. .

An FDA laboratory tested the samples and the sam ples
contained TAM C and TYM C in excessofacceptable lim its.Thesnmplesalso tested positive for
thepresence ofB.cepacia.
R A ID EL FIG IJER O A 'S False Statem ents to the FDA durine an FDA Inspection ofO fcus
Pharm a
Som etim e between October 2016 and Septem ber 2017,RAIDEL FIGUEROA
asked IndividualOneto telltheFDA during any inspection ofOfcusPharm athatIndividualOne
was the owner of Ofcus Phnnna and to notdisclose R ATDEL FIGUER OA'S ownership and
control of Ofcus Pharm a,when in tnzth and in fact,and as both R M DEL FIGUEROA and
IndividualOne then and there wellknew,any statem ent aboutlndividual One owning Ofcus
Phnrma w asfalse and failing to discloseR M DEL FIG U ER O A 'Sow nership and controlofOfcus
Pharm a w as rnisleading to the FDA .
46. On or aboutSeptem ber 1,2017,an FDA investigator initiated an inspection of
OfcusPhnrmainBrowardCotmty,Florida(tçseptember2017FDA InspectionofOfcusPharma''l.
Dlzring the inspection,Individual One advised the FDA investigator th>the had one htmdred
percent ownersl'
lip ofO fcusPhnnna,thathe w asthefolm derofOfcus,thathestarted the com pany
in October2016,when in tnzth andinfact,andasIndividualOnethen andtherewellknew,hedid
notown O fcus Phnrm a,he w asnotthe founderofO fcusPhnrm a,and he did notstartthe com pany
in O ctober2016.
CO UN T 1
C onspiracv to D efraud the U nited States
(18U.S'
.C.j371)
47. Paragraphs 1through 46 oftheGeneralA llegationssection ofthisIndictm entare
re-alleged and incorporatedby referenceasiffully setforthherein.
48. From on or aboutOctober 2016 tllrough on oraboutSeptember 2017,the exact
dates being llnknown to the Grand Jury,in Brow ard County,in the Southem District of Flolida,
and elsew here,the defendant,
R AIDEL FIG UE RO A ,
aIV a itltey Figueroa,''
a/k/a tdlèay Figueroa,''
did knowingly and willfully com bine,conspire,confederate,and agree with others,known and
Ilnknow n to the Grand Jury, to defraud the United States by im pairing, interfering with and
obstnlcting,through deceitfuland dishonestm eans,the law ftzlfilnctions ofthe FD A .
PurposeoftheConspiracy
lt was the ptlp ose of the conspiracy for RM DEL FIGUEROA and his co-
conspirators to m anufacttlre and distribute dnzgs outside the regulatory oversight ofthe FDA,
which interfered with and obstructed the FDA'Slawfulfunction ofregulating dnzg and dietary
supplem entm anufacturers.
M annerandM eansoftheConspiracy
Them nnnerand meansby which R AIDEL FIGUER OA and his co-conspirators
soughtto accom plish the purpose ofthe conspiracy included,butw asnotlim ited to:
a. Providing incom plete productlists to the FD A during the M arch - M ay 2017 FD A
Inspection ofPhnrmatech and representing to the FD A thatthese lists contained a11the

productsPhnrmatech hadm anufacttlred afteritresum ed manufacmring;
b. Falsely advisingtheFDA dlzring theM arch -M ay2017FDA Inspection ofPhnrmatech
thata11dataforPhase3 testing ofitswatersystem hadm etacceptancecriteria;
c. Failing to disclose to the FDA during the M arch - M ay 2017 FD A lnspection of
Phnrmatech ofRATDEL FIG UEROA'Scontrolofotherm anufacturinglocationsused
to m anufacttzre drug products and dietary supplem ents;
d. Failing to disclose to the FDA dlzring the M arch - M ay 2017 FD A Inspection of
Phnrmatech ofR M DEL FIGUEROA'Sownership and controlofOfcusPhnrma;
e. Falsely advisingtheFDA dtlringtheSeptember2017 FDA lnspection ofOfcusPharm a
thatIndividualOnewasthe soleownerofOfcusPhnrma;and
Failing to disclose to the FDA during the Septem ber2017 FDA Inspection ofOfcus
PhnnnathatRM DEL FIGUEROA contw lledOfcusPhnrma.

O vertA cts
lnfurtheranceoftheconspiracy,andtoachievetheobjectandpurposethereof,atleastone
ofthe conspiratorscomm itted and causedto becomm itted,in the Southem DistrictofFlorida,at
leastone ofthe follow ing overtacts,am ong others:
a. On oraboutM arch 20,2017,FDA investigatorsrequested RAIDEL FIGUEROA to
provideaproductlistofal1theproductsPhnrmatech hadm anufacturedafteritresllm ed
m antlfacttlring. In response,R AIDEL FIGUEROA caused a productlist,wllich he
then and therew ellknew did notincludeD iocto Liquid,to beprovided to the FD A and
falsely represented to the FDA as a com plete list of a1l the products that w ere
m anufactured afterPhnrm atech resum ed m anufactudng.
b. O n or about M arch 27,2017,FD A investigators discovered thatthe product listthat

w asprovidedtothem onoraboutM arch 20,2017,wasincompleteand again requested
RAIDEL FIGUEROA to provide acomplete listofal1theproductsPharmatech had
m anufactured afteritrestlm ed manufacturing. ln response,RATDEL FIGUEROA
caused asecondproductlist,which hethen andtherewelllcnew didnotincludeDiocto
Liquid,to be provided to the FD A and falsely represented to the FD A as a com plete
list of a1l the products that were manufacttzred after Pharmatech resllm ed
m anufacturing.
On or about April 4, 2017, R AIDEL FIG U ER OA caused a m em orandllm to be
provided to the FDA,which falsely stated to the FDA that,GW s ofthe date ofthis
m em o,a11data forPhase3 hasm etacceptance criteria,''when in truth and in fact,and
as R ATD EL FIG U ER OA then and there w ell lcnew ,a11data for Phase 3 testing of
Pharmatech's water system had not m et acceptance criteria because RAIDEL
FIGUER OA knew thata water sample taken on February 15,2017 from the water
system testedpresllmptivepositiveforthepresence ofB.cepacia.
d. Dudng theM azch -M ay 2017FDA Inspection,FDA investigatorsrequestedR ATDEL
FIGUEROA to identify any otheraffiliated businesseshe owned,even ifthey w ere
notregistered underllisnnme. ln response,R AIDEL FIGUEROA olnitted thefact
thathe owned and controlled OfcusPharma;and
e. Duringthe September2017FDA Inspection ofOfcusPhnnna,lndividualOne advised
the FD A that he solely owned Ofcus Pharm a, w hen in tnzth and in fact, and as
IndividualOne then and there w ellknew ,he did notown OfcusPhnrm a.
Allin violation ofTitle 18,United Stated Code,Sedion 371.

C O U NTS 2-4
Falsification ofR ecords in a FederalInvestigation
(18U.S.C.jj1519and2)
51. Paragraphs 1through 46 ofthe GeneralAllegationssection ofthislndictm entare
re-alleged and shallbe incorporated by reference into Counts2 through 4 ofthisIndictm entasif
setforth in fulltherein.
O n oraboutthe dateslisted below ,in the Southern D istrictof Florida,and elsewhere,the
defendant,
R AIDEL FIG U ER O A ,
a/k/a ddltey Figueroa,M
a/k/a ddltay Figueroa,''
aided and abetted by otherpersonsknown and unknown to the Grand Jury,knowingly altered,
covered up,falsified,and m ade false entry in doctlm ents provided to the FDA,by the actions
described below,with the intentto impede,obstnzct,and influencetheinvestigation and proper
administrationofanymatterwithinthejurisdictionoftheFDA,anagencyoftheUnitedStates:
CO U N T DA TE DE SCR IPTIO N '
On or about M arch 20,2017,FD A investigators

requested R AIDEL FIGUEROA to provide a
product list of a11 the products Phnrmatech had
m arm facttlred after itresum ed m anufacturing. T.
n
response, R AID EL FIG U ER O A caused a
2 M arch 20,2017 productlist,which hethen and therewellknew did
not include D iocto Liquid,to be provided to the
FDA and falsely represented to the FDA thatthe
productlistwasacompletelistofa11theproducts
thatw ere m armfactured afterPharmatech resllm ed
m armfacturing.
15
On or about M arch 27,2017,FD A investigators

discovered thatthe productlistthatw asprovided
to them on or about M arch 20, 2017 w as
incom plete and again requested R AID EL
FIGIJEROA to provide a complete listofa1lthe
products Phnrmatech had manufactured after it
3 M resumed m armfacturing. In response,R AIDEL
arch 27,2017 yac u su o x caused a second productlist,which
hethen andtherewellknew didnotincludeDiocto
Liquid,to be provided to the FDA and falsely
represented to the FDA thatthe productlistw as a
com plete list of al1 the products that w ere
m anufactured after Phnrm atech resllm ed
m anufacturing.
On oraboutApril4,2017,RAIDEL FIGUEROA
caused a m em orandllm to beprovided to the FDA ,
which falsely stated to the FDA that,tçA.s ofthe
date of this m em o, al1 data for Phase 3 has m et
acceptancecriteria,''when in truth and in fact,and
as RATDEL FIGUEROA then and there well
4 April4,2017 lcnew, that all data for Phase 3 testing of
Phnrmatech's water system had not m et
acceptance criteria because a water sample taken
on Febrtzary 15,2017from thewatersystem tested
presumptive positive for the presence of B.
ce acia.
A1lin violation ofTitle 18,United StatesCode,Sections 1519 and 2.
C O UN TS 5-8
O bstruction ofProceedingsBefore an A gency ofthe U nited States
(18U.S.C.jj1505and2)
52. Paragraphs 1through 46 ofthe GeneralAllegationssection ofthisIndictm entare
re-alleged and shallbeincorporated by reference into Colmts5through 8 ofthisIndictmentasif
setforth in f'u11therein.
On oraboutthedateslisted below,in the Southern Disttid ofFlorida,and elsewhere,the
defendant,
16
R AID EL FIG U ER O A ,
a/lt/a dltey Figueroa,''
a/k/a RR ay Figueroa,''
aided and abetted by persons lcnown and 'lnknown to the Grand Jury,by the actionsdescribed
below ,did cozruptly influence,obstnzct and im pede,and endeavored to intluence,obstnlct and
impede,thedueand properadm inistration ofthe1aw tmderwhich apendingproceedingwasbeing
had before an agency ofthe Urlited States of which the Defendantlcnew of,to wit,an FDA
inspection of Pharmatech'sm anufacttlring facility in Broward County,Florida,ptzrsuantto the
FD A 'S statm oly inspection authority setforth in Title 21,Urlited States Code,Section 374:
C O UN T DA TE D ESCR IPTIO N
OnoraboutMarch 20,2017,FDA investijators

requested R AIDEL FIG U ER O A to provlde a
Productlistof a11the products Phnrmatech had
m anufactlzred after itresllm ed m anufacturing. In
response, R AID EL FIG UER O A caused a
M arch 20,2017 productlist,whichhethenandtherewellknew did
notinclude Diocto Liquid,to be provided to the
FDA and falsely represented to the FDA thatthe
productlistwasacomplete listofa1ltheproducts
thatw ere m anufactuzed afterPharm atech resllm ed
m anufacturing.
On or aboutM arch 27,2017,FDA investigators

discovered thattheproductlistthatwasprovided
to them on or about M arch 20, 2017 w as
incomplete and ajain requested RAIDEL
FIGUEROA to provlde a complete listofallthe
products Pharmatech had m anufactlzred after it
6 M resum ed m arm facturing. ln response, R AID EL
arch 27,2017 FIG U ER O A caused a second product list,wllich
hethen and there w ellknew did notiriclude Diocto
Liquid, to be provided to the FD A and falsely
represented to the FDA thatthe productlistw as a
complete list of a11 the products that were
m anufacttzred after Phnrm atech resllm ed
m anufacturing.
On oraboutApril4,2017,RAIDEL FIGEROA
caused am em orandllm to be provided to the FDA ,
which falsely stated to the FDA that,G1As ofthe
date of this m emo,a1ldata for Phase 3 has m et
acceptancecriteria,''when intruth and in fact,and
7 A as RM DEL FIGUEROA then and there well
pdl4,2017 knew, tjaat a11 data for Phase 3 testing of
Phnrmatech's w ater system had not m et
acceptance criteria because a w ater sam ple taken
on Febnlary 15,2017 from the w atersystem tested
prestlm ptive positive for the presence of B.
cepacia.
Dlzring the M arch - M ay 2017 FDA lnspection,

Beginnl
.ng on orabout FD A investigators requested R ATD EL
March2017andcontinuing FIGUEROA to identify any other affiliated
8 businesses he owned, even lf they w ere not
through on oraboutM ay regjstered underhisnam e. ln response,R AID EL
2017 FIGUEROA intentionally om ittedthefactthathe
owned and controlled OfcusPharma.
A11in violation ofTitle 18,United StatesCode,Sections1505 and 2.
CO U N T 9
D istribution ofA dulterated D rugs in Interstate Com m erce
(21U.S.C.jj331(a)and333(a)(1))
53. Paragraphs 1 tllrough 46 ofthe GeneralAllegationssection ofthisIndictmentare
re-alleged andincop orated by referenceasiffully setfot'th herein.
On oraboutM azch 7,2017,in theSouthel'

n DistrictofFlorida,and elsewhere,the
defendant,
R AIDEL FIG UER O A ,

a/k/a <dlèey Figueroa,''
a/k/a SiR ay Figueroa,''
18
introduced and delivered for introduction into interstate commerce and caused to be introduced
and delivered for introduction into interstate commerce, adulterated drugs, to wit, bottles ofDiocto
Liquid, in that the Diocto Liquid consisted in whole and in part of any filthy, putrid, and
decomposed substance, in violation of21 U.S.C. § 35l(a)(l), and the Diocto Liquid was prepared,
packed, and held under insanitary conditions whereby it may have been contaminated with filth,
and whereby it may have been rendered injurious to health, in violation 21 U.S.C. § 351(a)(2)(A).
All in violation ofTitle 21, United States Code, Sections 33l(a) and 333(a)(l), and Title
18, United States Code, Section 2.
A TRUE BILL
FOREPERSON
��-�-jfr2-
JUAN ANTefNlO GONZALEZ
y
.t/Aftt,14t./S11
��
ASSISTANT UNITED STATES ATTORNEY
19
UM TED STATESDISTRICT COUU
SOW IIERN DISTRIG O F FLORIDA
X TED STATESO F AW W CA CASE NO.

V.
RAIDEL FIGUEROA, C ERTIFICATE OF TRIAL ATTORN EY*
a/k/a 'Rey Figueroa,''alèla 'Ray Figueroa,''
SupersedingCaseInformation:
Defendant. /
CourtDivision:tselectOne) Newdefendantts) I--IYes 1-1No
F-lMiami F-lKeyWest 1-
7-1F'I'
L Numberofnewdefendants
I
N WPB F-IF'I' P Totalnumberofcotmts
1.Ihavecarefully consideredtheallegationsoftheindictment,thenumberofdefendants,thenumberofproh ble
witnessesandthelegalcomplexitiesoftheIndictm entfnfonnation attachedhereto.
2.1am awarethattheinform ation supplied on thisstatementwillberelied upon by theJudgesofthisCourtin
settingtheircalendarsand scheduling criminaltrialstmderthemandateoftheSpeedy TrialAct,
Title28 U.S.C.Section 3161.
3.lnterpreter:(YesorNo) No
Listlanguageand/ordialect English
4. Thiscase willtake 15 daysforthepm iesto try.
5. Pleasecheck appropriatecategory andtypeofoffenselistedbelow:
(Checkonlyone) (Checkonlyone)
1 0to5days (7l Petty (7l
11 6to10days E7I Minor E7I
I1I 11to20days rzll Misdemeanor EE1
IV 21to60days E7I Felony Lz
V 61daysandover E7
6.HasthiscasepreviouslybeenfiledinthisDistrictCourt? (YesorNo) NO
Ifyes:Judge CaseNo.
(Attachcopyofdispositiveorder)
Hasacomplaintbeenfiledinthismatter? (YesorNo) No
lfyes:M agistrateCaseN o.
Relatedm iscellaneousnumbers:
Defendantts)infederalcustodyasof
Defendantls)instatecustodyasof
Rule20 from theDistrictof
Isthisapotentialdeathpenaltycase?(YesorNo) No
7. Doestlliscase originatefrom am atterpendingin theCentralRegion oftheU.S.Atlorney'sOffice priorto
August9,2013(M ag.JudgeAlicia0.Valle)?(YesorNo) No
8. Doesthiscase originatefrom am atterpending intheNorthern Region oftheU.S.Attorney'sOfficepriorto
August8,2014(M ag.JudgeShaniekM aynard?(YesorNo) No
9. Doesthiscase originatefrom am atterpending intheCentralRegion oftheU.S.Attorney'
sOfficepriorto
October3,2019(M ag.JudgeJaredStrauss)?(YesorNo) Yes
Rl CA
'
st e States Attorney
CourtID No. 151378
*penalty Sheetts)attachd lkEv 3/19/21
UM TED STATES DISTRICT COURT
SO U TH ER N DISTRIC T O F FLO R ID A
PEN A LTY SH EET
D efendant'sN am e:RA ID EL FIGU ERO A C aseN o:
Colm t: 1
Conspiracv to DefraudtheUnited States
18U.S.C.5 371
*M ax.Penalty: Five(5)years'imprisonment;three(3)years'supervisedrelease;$250,000fine.
Cotm ts:2-4
Falsification ofR ecordsin a FederalInvestigation
18 U.S.C.k 1519
*M ax.Penalty: Twen'ty (20)years'imprisonment;three(3)years'supervisedrelease'

,$250,000fine.
Colm ts:5-8
Obstnlction ofProcèedinzsBefore an Acencv oftheUnited States
18 U.S.C.6 1505
*M ax.Penalty: Five(5)years'impdsonment;three(3)years'supervisedrelease'
,$250,000fine.
Count:9
Distribution ofAdulterated Dnm sin InterstateComm erce
21U .S.C.6$331(a)and 333(a)(1)
*M ax.Penalty: One(1)yearimprisonment;one(1)yearsupervisedrelease;$1,000fine.
*Refers only to possible term of incarceration, does not include possible fines, restitution. special
assessments, parole terms or forfcitures that may be applicable.

Figueroa Indictment

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Figueroa Indictment

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Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 1 of 21

The Grand Jury chargesthat:

Ata11tim esm aterialto thisIndictm ent'

R elevant Corporate Entities

1. Phnrmatech,LLC (Kûphnrmatech'')wasan activeFloridacorporation,which was

m anufactured drugsand dietary supplem entsfordistlibutors.

CardinalHea1thwasadistlibutorofphnrm aceuticalsand am armfacturerofm edical

and laboratoryproducts. CardinalHealth om wd TheHarvardDnlg Group.

product called Gr iocto Liquid,''tmder the nnme Ellkugbyy''which Phnrmatech manufactured,

forthepup oseofm anufacm ring oralsolid drugsand dietary supplem ents.

From atleaston or aboutM arch 2016 through September2017,the defendant,

Pharm atech. Dllringthistim e,RAIDEL FIGUEROA representedtotheUnited StatesFood and

Cosm eticAct.Hefurtherrepresentedthathehad theresponsibility forpreventing,detecting,and

correcting any violations ofthose law s atPhnrm atech.

6. From on or about October 20,2016 through on or about December 15,2016,

RAIDEL FIGUEROA waslisted in cop oratefilingswith the StateofFloridaasthepresidentof

Presidentand TreastlrerofOfcusPhnrma,and on oraboutDecember 20,2016,lndividualOne

wasadded asthePresidentand TreasurerofOfcusPhnrma in cop orate filingswith the State of

Florida.Despitethesefilings,from on oraboutOctober20,2016through October2017,RAIDEL

The U nited States Food and D rue A dm inistration

enforcing theFederalFood,Drug,and CosmeticAct(lltheFDCA''),21U.S.C.j301etseq. In

regulating the manufactureand distribution ofdrugsand dietary supplements,enstzring thatdrtzgs

supplem ents were manufactured,processed,packed,and held,and investigating outbreaks of

irlfectionsrelated to potentially contnm inated drugs.

8. The FDCA defined a Gtdrug''in relevantpart,as an article intended foruse in the

diagnosis,clzre,m itigation,treatment,orprevention ofdisease in man or othernnimals,and an

it consisted in whole or in part of any filthy, putl'id or decomposed

factory,warehouse,orestablishm entin which drugsordietary supplem entswerem anufactured,

processed,packed,orheld,for introduction into interstate com merce oraftersuch introduction,

andto inspect,atreasonabletim esand witllin reasonable lim itsand in areasonablem nnner,such

m aterials,containers,and labeling therein.In thecaseofatly factory,warehouse,establishm ent,

orconsulting laboratory in wllich prescription dnzgsornonprescription drugs intended forhllm an

usewerem anufactured,processed,packed,orheld,theauthority to inspectextended to a1lthings

therein (including records,files,papers,processes,controlsand facilities)beadng on whether

m anufacturing facility R M DEL FIG UER O A owned orcontrolled.

From at least 2016 through at least M arch 2017,Phnrm atech m anufactlzred a

TheBacteriaBurltholderia cepacia (B.cepaciaj

15. Burkholderia cepacia($T.cepacia'')wasthenamefotagroup orGlcomplex''of

ltmg diseasesm ay havebeen m oresusceptibletoB.cepacia infections.TheeffectsofB.cepacia

m edicinescouldtransm itB.cepacia,andthebacteriawereoftenresistanttocom m on antibiotics.

FD A Inspection ofPharm atech in July - A ugust2016 and Pharm atech's

16. On oraboutJuly 5,2016,FDA regulatory investigators(CTDA investigators'')

into an outbreak ofB.cepacia infectionsand concern thatPharm atech'sDioctoLiquid m ay have

been a potentialsource ofthe infections.

investigatorsastheco-ownerand CEO ofPhnrmatech.Headmitledthathehadtheduty,authority,

19. In oraboutJuly 15,2016,Pharmatech voltmtadly recalled al1lutsofPhnrmatech's

Diocto Liquid lGin theinterestofpublic safety afteritwas discovered thatsom e bottlesm ay be

adulterated with Burkholderia cepacia.',

20. ln or about August 5, 2016, Phnrmatech issued a voluntary recall expansion

(GtAugust2016 recall'')to coveradditionalliquid productsGidueto a potentialrisk ofproduct

temporarily stoppedm anufacturing liquid products.

21. AtthecloseoftheJuly -August2016 FDA inspection,which occurredon orabout

A ugust 9, 2016, the FD A investigators issued an FD A Form 483 to R M D EL FIG U ER O A

notifying him of multiple inspectionalobservations identifying objectionable conditions at

inspection had tested positive forthe presence ofB.cepacia.

In or aboutAugust25,2016,R AIDEL FIG U ER O A provided a wlitten response

engineeringitsUSPPudtiedW aterSystem (tGwatersystem'')topreventcontnminationofthewater

Batch issueform anufacturing forliquidswas:07/14/16,and forsolidswas07/20/16.''

m anufactaring com pany.''

FDA R eeulatorv M eetinz w ith R M D EL FIG U ER O A on Januaa 17.2017

26. On or aboutJanuary 17,2017,the FD A held a regulatory m eeting w ith R ATDE L

Phnrmatech'stwo voltmtary recallsin 2016.