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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.

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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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
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