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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 [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.

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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Company Name Record Date FEI Number Record Type State Establishment Type Publish Date Excerpt
Maimonides Medical Center 3015468054 483 New York Producer of Sterile and Non Sterile Drug Products
First Royal Care Co. LLC dba Red Mountain Compounding 3015235235 State Referral Letter Arizona Producer of Sterile and Non Sterile Drug Products
MSLS LLC dba The Medicine Shoppe 3012814943 483 Missouri Producer of Non Sterile Drug Products
Apollo Care LLC 3013927023 483 Missouri Outsourcing Facility
Fresenius Kabi 3013438665 483 Massachusetts Outsourcing Facility
Palisades Compounding Pharmacy 3008174851 483 California Producer of Non Sterile Drug Products
Wedgewood Village Pharmacy 3001779702 Warning Letter Response New Jersey Producer of Sterile and Non Sterile Drug Products
Delta Pharma 3004034796 483 Mississippi Outsourcing Facility
BAYCARE INTEGRATED SERVICE CENTER 3013023419 483 Florida Outsourcing Facility
Central Admixture 3009590582 483 Pennsylvania Outsourcing Facility
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