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
Medical Center Pharmacy, Inc	11/18/2015	3010536120	483	Tennessee	Producer of Sterile Drug Products	04/19/2019
PharMEDium Services, LLC	11/12/2015	3000717703	483	Texas	Outsourcing Facility	04/19/2019
Advanced Infusion Solutions	03/24/2017	3011469631	483	Mississippi	Producer of Sterile Drug Products	04/19/2019
Pacific Healthcare, Inc. dba B & B Pharmacy	10/23/2015	3005530267	483	California	Producer of Sterile Drug Products	04/19/2019
Pine Pharmaceuticals	10/23/2015	3010943533	483	New York	Outsourcing Facility	04/19/2019
PharMEDium Services LLC	11/03/2015	3000717703	483	Texas	Producer of Sterile Drug Products	04/19/2019
Pharmacy Creations	09/01/2016	3003348498	483	New Jersey	Producer of Sterile Drug Products	04/19/2019
Marlborough Hospital	10/23/2015	1270482	State Referral Letter	Massachusetts	Producer of Sterile Drug Products	04/19/2019
Pharmaceutic Labs, LLC.	11/19/2015	3010750417	483	New York	Outsourcing Facility	04/19/2019
PharMEDium Services LLC	10/14/2015	3000717703	483	Texas	Outsourcing Facility	04/19/2019

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