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 [email protected]. 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 |
|---|---|---|---|---|---|---|---|
| Pharmacy Doctors Enterprises dba Zion Clinical Pharmacy | Other Correspondence | Florida | Producer of Sterile Drug Products | ||||
| American Specialty Pharmacy | 3012174424 | 483 | Texas | Outsourcing Facility | |||
| Terumo Cardiovascular Systems Corporation | 1828100 | 483 | Michigan | Medical Device Manufacturer | |||
| FY 2006 ORA Field Workplan Part I | Workplan | Maryland | |||||
| South Coast Specialty Compounding, Inc. | 483 | California | Producer of Sterile Drug Products | ||||
| FY 2001 ORA Field Workplan Part III | Workplan | Maryland | |||||
| Consumer Complaint Record | Maryland | ||||||
| Peregrina Cheese Company | 3002119179 | 483 | New York | Cheese Manufacturer | |||
| Plainview Milk Products Cooperative | 2117605 | 483 | Minnesota | Manufacturer | |||
| nSpired Natural Foods, Division of the Hain Celestial Group | 3003051915 | 483 | Oregon | Manufacturer |