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 |
|---|---|---|---|---|---|---|---|
| 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 | |||
| Magellan Rx Pharmacy, LLC | 3012729025 | FMD-145 Letter | New York | Producer of Sterile and Non Sterile Drug Products | |||
| Magellan Rx Pharmacy, LLC | 3012729025 | Other Correspondence | New York | Producer of Sterile and Non Sterile Drug Products | |||
| Pavilion Compounding Pharmacy | 3004570352 | Other Correspondence | Georgia | Producer of Sterile and Non Sterile Drug Products | |||
| Pavilion Compounding Pharmacy | 3004570352 | 483 | Georgia | ||||
| AveXis | 3014617030 | Establishment Inspection Report (EIR) | California | Control Testing Laboratory | |||
| Joe Wise Pharmacy, Inc. dba Wise Pharmacy | 3004995630 | 483 | Colorado | Producer of Sterile and Non Sterile Drug Products | |||
| Crawford's Professional Drugs, Inc. dba Diket's Professional Drugs, Inc. | 3014539091 | State Referral Letter | Mississippi | Producer of Sterile and Non Sterile Drug Products |