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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
Wells Pharmacy, Inc 3011761321 483 Tennessee Outsourcing Facility
Emergent Manufacturing Operations Baltimore LLC 3015448605 483 Maryland Contract Testing Laboratory
Midwestern Pet Foods Chickasha Operation 3006701521 483 Oklahoma Pet Food Manufacturer
Absolute Veterinary Compounding Pharmacy 3008790859 FMD-145 Letter Texas Producer of Sterile and Non Sterile Drug Products
Village Pharmacy 3007537202 FMD-145 Letter New Jersey Producer of Non Sterile Drug Products
Emergent Manufacturing Operations Baltimore, LLC. 3015448605 483 Maryland Vaccine Manufacturer
Emergent Manufacturing Operations Baltimore LLC 3015448605 483 Response Maryland Contract Testing Laboratory
Hospira Inc 1925262 483 Kansas Sterile Drug Manufacturer
Juno Therapeutics, Inc. 3011834594 Establishment Inspection Report (EIR) Washington CAR-T Cell Therapy Manufacturer
3015212514 483 Minnesota Sponsor
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