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 ORAOSPOPFOIReadingRoom@fda.hhs.gov. 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 |
|---|---|---|---|---|---|---|---|
| Hybrid Pharma LLC | 3011319445 | 483 Response | Florida | Outsourcing Facility | |||
| Sentara Enterprises | 3025984445 | State Referral Letter | Virginia | Producer of Sterile Drug Products | |||
| Empower Clinic Services LCC dba Empower Pharmacy | 3021758709 | 483 | Texas | Producer of Sterile and Non Sterile Drug Products | |||
| Wedgewood Connect, LLC | 3003434972 | 483 | California | Outsourcing Facility | |||
| Catalent Indiana, LLC | 3005949964 | 483 | Indiana | Manufacturer | |||
| SCA Pharmaceuticals, LLC. | 3013736415 | 483 Response | Connecticut | Outsourcing Facility | |||
| Hybrid Pharma LLC | 3011319445 | 483 | Florida | Outsourcing Facility | |||
| Stokes Healthcare Inc. | 3002815949 | 483 | New Jersey | Outsourcing Facility | |||
| SCA Pharmaceuticals, LLC. | 3013736415 | 483 | Connecticut | Outsourcing Facility | |||
| Kilitch Healthcare India Limited | 3011853060 | 483 | Sterile Drug Manufacturer |