ORA FOIA Electronic Reading Room
The ORA Electronic Reading Room displays copies of ORA domestic inspection and related records. We are making these records publicly available either (1) proactively at our discretion or (2) because they are "frequently requested" per the Electronic Freedom of Information Act Amendments of 1996. Some records may be redacted to remove non-public information (see 21 CFR Part 20). For publicly available ORA data sets, (such as lists of inspection classifications, 483 observations, etc.), please visit the data sets page. For other ORA documents, please visit the ORA home page and the FDA Warning Letter page. For foreign inspection and related records, please search the relevant center reading room page on the main FDA Electronic Reading Room.
In the event you are unable to read these documents or portions thereof, please contact ORA’s Division of Information Disclosure Policy [email protected]. If you are unable to find documents that you are looking for you may file a FOIA request for the records at https://www.fda.gov/regulatory-information/freedom-information/how-make-foia-request.
To find FOIA archived content for years prior to 2012, visit https://wayback.archive-it.org/7993/20170404012657/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/default.htm.
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| Record Date | Company Name | FEI Number | Record Type | State | Establishment Type | Publish Date | Excerpt |
|---|---|---|---|---|---|---|---|
| iRhythm Technologies Inc. | 3007208829 | 483 | California | Manufacturer | |||
| iRhythm Technologies Inc. | 3021769057 | 483 | California | Medical Device Manufacturer | |||
| Nubratori, Inc | 3010166491 | 483 | California | Outsourcing Facility | |||
| Hikma Injectables USA Inc. | 3022897129 | 483 | New Jersey | Outsourcing Facility | |||
| Carie Boyd Pharmaceuticals | 3010589333 | 483 | Texas | Outsourcing Facility | |||
| Hikma Pharmaceuticals USA Inc. | 2220525 | 483 | New Jersey | Outsourcing Facility | |||
| Wickliffe LLC | 3002992930 | Untitled Letter | Kentucky | Producer of Sterile and Non Sterile Drug Products | |||
| Olympia Compounding Pharmacy dba Olympia Pharmacy | 3009724085 | 483 | Florida | Outsourcing Facility | |||
| SKNV | 3012384835 | 483 | Florida | Outsourcing Facility | |||
| Brookfield Medical Surgical Supplies | 3011430551 | 483 | Connecticut | Outsourcing Facility |