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ORA FOIA Electronic Reading Room

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.

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Company Name Record Date FEI Number Record Type State Establishment Type Publish Date Excerpt
Promise Pharmacy, LLC 3013207472 483 Florida Producer of Sterile Drug Products
The Wellness Center Pharmacy, Inc., dba Designer Drugs 3004578635 State Referral Letter Tennessee Producer of Non Sterile Drug Products
Denver Solutions, LLC dba Leiter's Health 3013438582 FMD-145 Letter Colorado Outsourcing Facility
John’s Pharmacy Inc. 1456985 483 Illinois Producer of Non Sterile Drug Products
Algunas Inc., dba Woodland Hills Compounding Pharmacy 3011830726 483 California Producer of Sterile Drug Products
JCB Laboratories LLC 3004839646 483 Kansas Outsourcing Facility
Diversified Pharmacy Inc dba University Compounding Pharmacy 3011130315 State Referral Letter Michigan Producer of Sterile Drug Products
Hospira Inc, A Pfizer Company 1925262 483 Kansas Drug Manufacturer
Millers of Wyckoff, Inc. 3004600183 FMD-145 Letter New Jersey Producer of Sterile and Non Sterile Drug Products
Cantrell Drug Company 3004483441 483 Arkansas Outsourcing Facility
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