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
Promise Pharmacy, LLC	10/25/2018	3013207472	483	Florida	Producer of Sterile Drug Products	05/13/2019
Quinn Pharmacy dba Northland Discount Drug Inc.	08/16/2018	3005011432	483	Mississippi		05/09/2019
MedisourceRx	09/27/2018	3013316698	483	California	Outsourcing Facility	05/09/2019
Sincerus Florida, LLC	09/17/2018	3012384835	483	Virginia	Outsourcing Facility	05/09/2019
MedisourceRx	09/27/2018	3013316698	483	California	Outsourcing Facility	05/09/2019
San Diego Compounding Pharmacy	10/25/2018	3006072852	483	California	Producer of Sterile Drug Products	04/30/2019
IntegraDose Compounding Services LLC	09/19/2018	3014483112	483	Minnesota	Outsourcing Facility	05/09/2019
Pharmacy Doctors Enterprises dba Zion Clinical Pharmacy	08/17/2018	3013918415	Other Correspondence	Florida		05/09/2019
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy	09/07/2018	3014391500	483	Kentucky		05/09/2019
Maag Prescription Center LLC	09/28/2018	3014481174	483	Idaho	Producer of Sterile Drug Products	05/09/2019

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