OII FOIA Electronic Reading Room
The OII Electronic Reading Room displays copies of select foreign and domestic inspection and related records. This database does not necessarily reflect all inspections or oversight activities that may satisfy the statutory inspectional requirements. For that reason, the absence of a particular facility from the public database should not be interpreted to mean that the facility has not been subject to appropriate regulatory oversight or that the annual inspection requirement has not been met.
The frequency and timing of inspections are determined based on a variety of factors, including risk, compliance history and available information.
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 OII 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 other inspection and related records, please search the relevant center reading room page on the main FDA Electronic Reading Room.
FDA is committed to ensuring digital accessibility for people with disabilities. We are continually improving the user experience for everyone and applying the relevant accessibility standards. At the time of initial posting, some records may not be fully accessible to users using assistive technology. If this is the case, a fully accessible version of the record is in preparation and will be posted as soon as it is ready. We regret any inconvenience that this may cause our readers. Please let us know if you encounter accessibility barriers by contacting 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.
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 | Country | Establishment Type | Publish Date | Excerpt |
|---|---|---|---|---|---|---|---|---|
| Turbare Manufacturing | 3027507354 | 483 | Arkansas | Outsourcing Facility | ||||
| Annovex Pharma Inc | 3020928491 | 483 | Virginia | Outsourcing Facility | ||||
| Denver Solutions LLC dba Leiters Health | 3013438582 | Untitled Letter | Colorado | Outsourcing Facility | ||||
| Sincerus Florida, LLC | 3012384835 | 483 | Florida | Outsourcing Facility | ||||
| Richmond VA Medical Center | 1174302 | 483 | Virginia | Producer of Sterile Drug Products | ||||
| VA San Diego Healthcare Systems | 2071629 | 483 | California | Producer of Sterile Drug Products | ||||
| Alvotech Hf | 3013702557 | 483 | Iceland | Biological Drug Substance/Product Manufacturer | ||||
| QuVa Pharma Inc | 3012053582 | 483 | Texas | Outsourcing Facility | ||||
| Mixlab WI LLC | 3005946041 | Untitled Letter | Wisconsin | Producer of Non Sterile Drug Products | ||||
| Catalent Indiana LLC | 3005949964 | 483 | Indiana | Sterile Drug Manufacturer |