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.

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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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FOIA Record Type - Any - 483 483 Response Adverse Determination Letter Adverse Determination Letter Response Amended 483 Consent Decree Consent Decree Correspondence Consumer Complaint Record Establishment Inspection Report (EIR Exhibits and Attachments FDA Requested Recall Letter FMD-145 Letter Investigation Memo Memo Other Correspondence Recall Record Receipt of Payment Letter Response Resumption of Operations Authorization Letter Sample Record State Referral Letter >Untitled Letter Warning Letter Response Workplan

Company Name	Record Date	FEI Number	Record Type	State	Establishment Type	Publish Date	Excerpt
Maimonides Medical Center	03/09/2023	3015468054	483	New York	Producer of Sterile and Non Sterile Drug Products	07/06/2023
First Royal Care Co. LLC dba Red Mountain Compounding	02/13/2023	3015235235	State Referral Letter	Arizona	Producer of Sterile and Non Sterile Drug Products	07/06/2023
MSLS LLC dba The Medicine Shoppe	09/28/2022	3012814943	483	Missouri	Producer of Non Sterile Drug Products	07/06/2023
Apollo Care LLC	04/05/2023	3013927023	483	Missouri	Outsourcing Facility	07/13/2023
Fresenius Kabi	03/06/2023	3013438665	483	Massachusetts	Outsourcing Facility	07/13/2023
Palisades Compounding Pharmacy	03/15/2023	3008174851	483	California	Producer of Non Sterile Drug Products	07/13/2023
Wedgewood Village Pharmacy	10/17/2022	3001779702	Warning Letter Response	New Jersey	Producer of Sterile and Non Sterile Drug Products	08/23/2023
Delta Pharma	06/02/2023	3004034796	483	Mississippi	Outsourcing Facility	08/23/2023
BAYCARE INTEGRATED SERVICE CENTER	06/02/2023	3013023419	483	Florida	Outsourcing Facility	07/28/2023
Central Admixture	03/30/2023	3009590582	483	Pennsylvania	Outsourcing Facility	07/27/2023

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