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OII FOIA Electronic Reading Room

The OII Electronic Reading Room displays copies of OII 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 OII documents, please visit the OII 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 OII’s Division of Information Disclosure Policy OIIFOIAInquiries@fda.hhs.gov.

To obtain a copy of a record not listed in the OII 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
OSRX Inc. 3014549846 483 Montana Outsourcing Facility
TAILSTORM HEALTH INC 3022483154 483 Arizona Outsourcing Facility
Avenue Pharmacy Inc dba Pathway Pharmacy 3010810839 483 Florida Producer of Non Sterile Drug Products
Brookfield Medical Surgical Supply 3011430551 Untitled Letter Connecticut Outsourcing Facility
Nephron Sterile Compounding Center 3011158388 483 South Carolina Outsourcing Facility
Staska Pharmaceuticals Inc 3017473850 483 Nebraska Outsourcing Facility
Precision Equine LLC 3005698544 Untitled Letter Response California Producer of Sterile and Non Sterile Drug Products
SSM Health Care St Louis 1972829 483 Missouri Outsourcing Facility
Annovex Pharma, Inc 3020928491 483 Virginia Outsourcing Facility
Mark Cuban Cost Plus 3024611767 483 Texas Outsourcing Facility
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