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.
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 |