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
Infusion Partners, LLC	03/28/2019	3013995728	State Referral Letter	Ohio	Producer of Sterile Drug Products	05/26/2020
Stone Oak Pharmacy	03/14/2019	3011954212	FMD-145 Letter	Texas	Producer of Sterile Drug Products	05/26/2020
Maryland Specialty and Compounding Pharmacy, LLC (formerly Professional Arts	03/11/2019	3004514280	FMD-145 Letter	Maryland	Producer of Sterile Drug Products	05/27/2020
Empower Clinic Services, LLC dba Empower Pharmacy	04/02/2019	3011887629	FMD-145 Letter	Texas	Outsourcing Facility	05/27/2020
Nutrishare Inc.	03/04/2020	3007957196	FMD-145 Letter	Kentucky	Producer of Sterile Drug Products	05/04/2020
Professional Pharmacy Services, Inc. dba Good Day Pharmacy	04/14/2020	3015414747	FMD-145 Letter	Colorado	Producer of Sterile and Non Sterile Drug Products	05/04/2020
Professional Pharmacy Services, Inc. dba Good Day Pharmacy	04/14/2020	3015414747	State Referral Letter	Colorado	Producer of Sterile and Non Sterile Drug Products	05/04/2020
One Way Drug dba Partell Specialty Pharmacy	11/25/2019	3011769075	483	Nevada	Producer of Non Sterile Drug Products	05/04/2020
Flourish Integrative Pharmacy, LLC dba Flourish Pharmacy	04/15/2020	3010710511	FMD-145 Letter	Oklahoma	Producer of Non Sterile Drug Products	05/04/2020
Pentec Health, Inc.	04/09/2020	3012746140	FMD-145 Letter	Pennsylvania	Outsourcing Facility	05/04/2020

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