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.

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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
Novartis Pharmaceuticals Corporation	08/08/2023	3010353512	Untitled Letter	New Jersey	Manufacturer	12/05/2023
Palisades Compounding Pharmacy	09/27/2023	3008174851	Untitled Letter	California	Producer of Non Sterile Drug Products	12/05/2023
Pine Pharmaceuticals LLC	09/19/2023	3010943533	483	New York	Outsourcing Facility	11/01/2023
New Vitalis Pharmacy LLC	07/05/2023	3014391500	483	Kentucky	Producer of Sterile and Non Sterile Drug Products	11/01/2023
SterRx LLC	06/28/2023	3010840309	483	New York	Outsourcing Facility	11/01/2023
Central Admixture Pharmacy Services, Inc.	07/31/2023	3014307835	483	Arizona	Outsourcing Facility	11/15/2023
Healthy Choice	07/15/2022	3013118095	Untitled Letter	New York	Producer of Non Sterile Drug Products	10/12/2023
Kilitch Healthcare India Limited	10/20/2023	3011853060	483		Sterile Drug Manufacturer	11/28/2023
CareFirst	12/04/2022	3012258924	483 Response	New Jersey	Producer of Sterile and Non Sterile Drug Products	06/26/2023
CareFirst Specialty Pharmacy LLC	03/31/2023	3012258924	State Referral Letter	New Jersey	Producer of Sterile and Non Sterile Drug Products	06/26/2023

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