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
Revive Rx Pharmacy	06/30/2023	3016710945	Untitled Letter	Texas	Producer of Sterile and Non Sterile Drug Products	10/12/2023
Surgery Pharmacy Services Inc	07/07/2023	3010704905	483	Tennessee	Producer of Sterile Drug Products	10/12/2023
Strive Pharmacy Texas LLC	09/08/2023	3015826784	483	Texas	Producer of Sterile and Non Sterile Drug Products	10/12/2023
Delta Pharma	06/02/2023	3004034796	483	Mississippi	Outsourcing Facility	08/23/2023
Wedgewood Village Pharmacy	10/17/2022	3001779702	Warning Letter Response	New Jersey	Producer of Sterile and Non Sterile Drug Products	08/23/2023
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
SNF Holdings LLC	03/02/2023	3021886842	483	Michigan	Producer of Non Sterile Drug Products	09/27/2023
Novartis Pharmaceuticals Corporation	08/08/2023	3010353512	Untitled Letter	New Jersey	Manufacturer	12/05/2023

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