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.

---

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.

 RSS Feed for ORA FOIA Electronic Reading Room

Search

Filter by

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
Prescription Alternatives, Inc.	11/16/2018	3014597508	483	Colorado	Producer of Sterile Drug Products	04/30/2019
Med Shop Total Care Inc.	11/01/2018	3002835459	483	Texas	Producer of Sterile Drug Products	04/30/2019
PolarityTE, Inc	07/13/2018	3014453293	483	Utah	Manufacturer	05/09/2019
Westlab Pharmacy, Inc. dba Westlab Pharmacy	08/15/2018	3007426960	483	Florida		05/09/2019
McGuff Compounding Pharmacy Services, Inc.	08/17/2018	3005031360	FMD-145 Letter	California	Producer of Sterile Drug Products	11/19/2019
Qualgen LLC	09/13/2018	30112866349	483	Oklahoma	Outsourcing Facility	05/09/2019
Pentec Health, Inc.	08/31/2018	3012746140	FMD-145 Letter	Pennsylvania	Outsourcing Facility	05/09/2019
Promise Pharmacy, LLC	11/12/2018	3013207472	483	Florida	Producer of Sterile Drug Products	04/30/2019
Dorneyville Pharmacy	09/28/2018	3005231215	483	Pennsylvania	Producer of Sterile Drug Products	05/09/2019

Download XLSX

Download XLSX