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.
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 |
---|---|---|---|---|---|---|---|
United Pharmacy, LLC | 3010404505 | 483 | Florida | Producer of Sterile Drug Products | |||
Mytilini Enterprises LLC dba Bedford Pharmacy Inc. | 3003687986 | 483 Response | New Hampshire | Producer of Sterile Drug Products | |||
University Rx Specialists Inc | 3004599113 | 483 | California | Producer of Sterile Drug Products | |||
Prescription Labs, Inc. dba Greenpark Compounding Pharmacy | 3009712882 | 483 | Texas | Producer of Sterile Drug Products | |||
Dignity Health-Northridge Hospital Medical Center | 2074359 | 483 | California | Producer of Sterile Drug Products | |||
Lato Drug Co., Inc. dba Post Haste Pharmacy | 3004709093 | FMD-145 Letter | Florida | Producer of Sterile Drug Products | |||
American Specialty Pharmacy, Inc. dba ASP Cares | 3012174424 | FMD-145 Letter | Texas | Outsourcing Facility | |||
Keystone Pharmacy | 3004488698 | 483 | Michigan | Producer of Sterile Drug Products | |||
SSM Health Care St. Louis DBA SSM St. Clare Health Center | 1972829 | 483 | Missouri | Outsourcing Facility | |||
Trone Health Services, Inc. | 3012086997 | 483 | Idaho | Producer of Sterile Drug Products |