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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.

Content for the ORA FOIA Electronic Reading Room is available on FDA's website for five years before being archived.

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
Wickliffe LLC 3002992930 State Referral Letter Kentucky Producer of Sterile and Non Sterile Drug Products
Triad Rx, Inc. 3013497126 State Referral Letter Alabama Producer of Non Sterile Drug Products
Triad Rx, Inc. 3013497126 Warning Letter Response Alabama Producer of Non Sterile Drug Products
Wedgewood Pharmacy 3003434972 Untitled Letter New Jersey Outsourcing Facility
Delta Pharma, Inc. 3004034796 483 Mississippi Outsourcing Facility
Jubilant DraxImage Radiopharmacies Inc. 3009339218 483 Florida Nuclear Pharmacy
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
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