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.
To obtain a copy of a record not listed in the ORA Reading Room please submit a FOIA request.
Follow the steps outlined on the following webpage to complete an online FOIA request: https://www.accessdata.fda.gov/scripts/foi/FOIRequest/requestinfo.cfm. (Note: As of 3/12/2020, we are asking that all FOIA requests be submitted through our online portal rather than by mail, fax, or courier, to ensure timely logging of the requests.)
Any questions related to FOIA requests may be addressed to the Division of the Freedom of Information Offices at (301) 796-3900. You may also visit the following webpages to learn more about FOIA requests:
https://www.fda.gov/regulatory-information/freedom-information/how-make-foia-request
https://www.accessdata.fda.gov/scripts/foi/FOIRequest/index.cfm.
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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| Record Date | Company Name | FEI Number | Record Type | State | Establishment Type | Publish Date | Excerpt |
|---|---|---|---|---|---|---|---|
| SSM Health Care St Louis | 1972829 | 483 | Missouri | Outsourcing Facility | |||
| Belcher Pharmaceuticals LLC | 1000526113 | 483 | Florida | Outsourcing Facility | |||
| Jubilant DraxImage Radiopharmacies Inc. | 3009339218 | State Referral Letter | Florida | Nuclear Pharmacy | |||
| iRhythm Technologies Inc. | 3007208829 | 483 | California | Manufacturer | |||
| iRhythm Technologies Inc. | 3021769057 | 483 | California | Medical Device Manufacturer | |||
| Precision Equine LLC | 3005698544 | Untitled Letter | California | Producer of Sterile and Non Sterile Drug Products | |||
| Nubratori, Inc | 3010166491 | 483 | California | Outsourcing Facility | |||
| Hikma Injectables USA Inc. | 3022897129 | 483 | New Jersey | Outsourcing Facility | |||
| Carie Boyd Pharmaceuticals | 3010589333 | 483 | Texas | Outsourcing Facility | |||
| Hikma Pharmaceuticals USA Inc. | 2220525 | 483 | New Jersey | Outsourcing Facility |