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Figueroa Indictment
Figueroa Indictment
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
G EN ER AL A LLEG A TIO N S
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
Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 2 of 21
OfcusPhnrma,Inc.(GçofcusPhnrma'')wasaFloridacorporation,incorporated on
oraboutOctober20,2016,andlocatedinBroward County,Florida.OfcusPhnrmawasestablished
The D efendant
R AID EL FIG UER O A , w as a co-ow ner of Pharm atech, and the Chief Executive Ofd cer of
DnlgAdministration(G1FDA'')thathehadtheduty,responsibility,andauthorityforenstuingthat
Phnrmatech'sproductscomplied with a1lrelevantlaws,including the FederalFood,Dnlg,and
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
FIG U ER O A rem ained the owner of Ofcus Pharma and ultim ately controlled the operations of
OfcusPhnrm a.
Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 3 of 21
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
were safe and effective for their intended uses,inspecting facilities where drugs and dietary
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:
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).
Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 4 of 21
11. Under the FDCA,the FDA had the authority to enter,atreasonable tim es,any
factoly, warehouse, or establishm ent and all pertinent equipm ent, finished and unfizlished
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
D iocto Liquid
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).
Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 5 of 21
people,butpeople w ho had certain health problem s like w eakened im m une system s orcllronic
could include sedous respiratory infections and other types of irlfections. Contnm inated
18. D tlring the inspection, R AID EL FIG U ER O A identified him self to the FD A
gnd responsibility to prevent, deted, and corred violations, and that all supervisory level
employeesreported tohim .
contam ination with Btlrkholderia Cepacia.'' In or about July/August of 2016, Pharm 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
to the FD A Form 483 advising ofcorrective actions Phnrm atech w as undertnking,including re-
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
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
FIGUEROA forthepurposesof:(1)givingPharmatechtheopportunitytodiseussthecompany's
Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 7 of 21
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
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
28. The FDA advised R AIDE L FIG U ER OA thatthe FD A still had concem s about
alleviated by an FD A inspection. The FDA asked R AID EL FIG UER O A to voltm tarily inform
D istribution ofD iocto Liquid on M arch 7.2017 to The H arvard D ruz G roup - Lot#
20351701
lcnowledge.
2016 B.cepacia outbreak investigation and evaluate the current and future public health risk
operations atthe firm,including the hiring and tiring of employees and thathe had the duty,
provide a product list of a11 the products Phnrmatech had m anufacttlred aftér it restlmed
m anufacturing.
w asprovided to them on oraboutM arch 20,2017,w asincom plete and again requested R AIDEL
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
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
presumptivepositiveforthepresenceofB.cepacia.
RAIDEL FIG UEROA identify any otheraffiliated businesseshe owned,even ifthey werenot
multipleinspectionalobservationsidentifyingobjectionableconditionsatPhnrmatech.
9
Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 10 of 21
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
atStanfordChildren'sHealthLucilePackardChildren'sHospital,(StanfordCEldren'sHealth)in
Palo Alto,California and atJohnsHopldnsChildren's Center tlohnsHopldns)in Baltimore,
M aryland.
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.
FDA laboratory tested thesnm plesand one ofthe gnm plescontained totalaerobicm icrobialcounts
Pharm atech's D iocto Liquid Lot #20351701 from Johns H opldns in M aryland. An FD A
10
Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 11 of 21
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
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
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
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
notown O fcus Phnrm a,he w asnotthe founderofO fcusPhnrm a,and he did notstartthe com pany
in O ctober2016.
Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 12 of 21
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
dates being llnknown to the Grand Jury,in Brow ard County,in the Southem District of Flolida,
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
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
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:
thatIndividualOnewasthe soleownerofOfcusPhnrma;and
Failing to disclose to the FDA during the Septem ber2017 FDA Inspection ofOfcus
lnfurtheranceoftheconspiracy,andtoachievetheobjectandpurposethereof,atleastone
ofthe conspiratorscomm itted and causedto becomm itted,in the Southem DistrictofFlorida,at
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
list of a1l the products that were manufacttzred after Pharmatech resllm ed
m anufacturing.
provided to the FDA,which falsely stated to the FDA that,GW s ofthe date ofthis
as R ATD EL FIG U ER OA then and there w ell lcnew ,a11data for Phase 3 testing of
FIGUER OA knew thata water sample taken on February 15,2017 from the water
the FD A that he solely owned Ofcus Pharm a, w hen in tnzth and in fact, and as
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.
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
administrationofanymatterwithinthejurisdictionoftheFDA,anagencyoftheUnitedStates:
CO U N T DA TE DE SCR IPTIO N '
15
Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 16 of 21
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.
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
setforth in f'u11therein.
defendant,
16
Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 17 of 21
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
had before an agency ofthe Urlited States of which the Defendantlcnew of,to wit,an FDA
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
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.
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
defendant,
18
Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 19 of 21
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
A TRUE BILL
FOREPERSON
��-�-jfr2-
JUAN ANTefNlO GONZALEZ
y
.t/Aftt,14t./S11
��
ASSISTANT UNITED STATES ATTORNEY
19
Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 20 of 21
UM TED STATESDISTRICT COUU
SOW IIERN DISTRIG O F FLORIDA
Rl CA
'
st e States Attorney
CourtID No. 151378
*penalty Sheetts)attachd lkEv 3/19/21
Case 0:22-cr-60033-JIC Document 1 Entered on FLSD Docket 03/02/2022 Page 21 of 21
UM TED STATES DISTRICT COURT
SO U TH ER N DISTRIC T O F FLO R ID A
Colm t: 1
18U.S.C.5 371
*M ax.Penalty: Five(5)years'imprisonment;three(3)years'supervisedrelease;$250,000fine.
Cotm ts:2-4
18 U.S.C.k 1519
18 U.S.C.6 1505
*M ax.Penalty: Five(5)years'impdsonment;three(3)years'supervisedrelease'
,$250,000fine.
Count:9
*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.