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OII FOIA Electronic Reading Room

About the OII Electronic Reading Room

The Office of Inspections and Investigations (OII) Electronic Reading Room gives the public access to selected FDA inspection and related records from both U.S. and foreign facilities.  Records are posted here either because FDA has chosen to share them proactively or because enough members of the public have requested them under the Freedom of Information Act (FOIA). See the Proactive Disclosure and Three or More Rule sections below for more details.

Important Caveat: 

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 this public database should not be interpreted to mean that the facility has not been subject to appropriate regulatory oversight or that the inspection requirements have not been met. 

The frequency and timing of inspections are determined based on a variety of factors, including risk, compliance history, and available information.

How Records Are Made Available

FDA posts records in this Reading Room through two distinct pathways: Proactive Disclosure and Three or More Rule under FOIA. Both are explained in the sections below. Records that do not qualify under either pathway will not appear here, even if an inspection took place.

It is also important to know that some records posted here may have portions redaction. This is done to protect information that is not appropriate for public release, such as trade secrets, confidential commercial information, personal information, or details that could compromise ongoing regulatory or law enforcement actions. This is governed by 21 CFR Part 20, FDA's public information regulations.

If you are looking for OII data sets, such as lists of inspection classifications or 483 observations, please visit the data sets page. For other OII documents, visit the OII home page or the FDA Warning Letter page. For inspection and related records maintained by other FDA programs or centers, visit the relevant center Reading Room on the main FDA Electronic Reading Room.

Proactive Disclosure

Under federal law (specifically 5 U.S.C. § 552(a)(2)), FDA is authorized and encouraged to post certain records online without waiting for someone to ask for them. This is called proactive disclosure. FDA does this when it determines that the public has a meaningful interest in the information and that sharing it serves the goals of transparency and accountability. You do not need to file a FOIA request to access proactively posted records; they are available to anyone who visits this page.

However, proactive disclosure is selective. FDA reviews records and makes case-by-case decisions about what to post. Not every inspection record will be posted proactively, and the absence of a record does not mean it does not exist or that it cannot be requested through FOIA.

Three or More Rule

Federal law also requires FDA to post records online when three or more people or organizations have separately requested the same record through FOIA. See 5 U.S.C. § 552(a)(2)(D). This is known as the "three or more rule," and it is one of the key transparency requirements of the Electronic Freedom of Information Act Amendments of 1996. The idea behind this rule is straightforward: If enough members of the public are asking for the same record, it should be made available to everyone rather than processed one request at a time. This saves time for both the public and the agency.

Many of the records you will find in this Reading Room are here because they met this threshold. If a record has not yet been requested three or more times and was not selected for proactive posting, it will not appear here, but it may still be available through a FOIA request.

What This Reading Room Does Not Include

This Reading Room is not a comprehensive repository of all FDA inspection activity. There are several important reasons that certain records may not be available here, and we want to be transparent about all of them.

When Records Are Temporarily Withheld

One of the most important limitations involves inspections that are still open or where FDA is actively pursuing a compliance action. When FDA is in the middle of a regulatory response, posting the related inspection records could interfere with that process. Federal regulations (21 CFR 20.64(d)) allow FDA to temporarily withhold these records until the compliance action is completed or the matter is otherwise resolved.

This means a facility may have been inspected, with records on file, that do not yet appear in this Reading Room simply because the regulatory process is still underway. Once the matter is closed, records may become available through proactive posting or a FOIA request.

A record not found is not the same as a missing inspection. Records may not appear in this Reading Room because a compliance action is still underway, because the record has not been frequently requested, or because FDA has not determined that proactive release is appropriate. 

Other Categories of Records Not Included Here

  • Records from other FDA centers and offices: Each center maintains its own FOIA Reading Room, which can be accessed through the main FDA Electronic Reading Room.
  • Records withheld under FOIA exemptions: Even when a record exists, portions or all of it may be withheld if it falls under one of the nine FOIA exemptions. 
  • Form FDA 483s and EIRs: Not all inspectional observations (Form FDA 483s) or Establishment Inspection Reports (EIRs) are publicly posted. Whether a 483 or EIR appears in this Reading Room depends on whether it qualifies under proactive disclosure or the three or more rule.
  • Company responses to FDA 483s or Warning Letters: When FDA issues an inspectional observation or a Warning Letter, the facility typically submits a written response. Those responses are generally not posted in this Reading Room unless they have been separately released through a FOIA request or proactive disclosure.
  • Records not yet meeting the three or more threshold: If fewer than three people have requested a particular record and it was not selected for proactive posting, it will not appear here. You may still request it through FOIA.
  • Records older than five years: Records are kept on this site for five years before being archived. Older records may not be accessible through this page. See the Archived Content section below for how to find them. 

Accessibility

FDA is committed to ensuring that all of its publicly available records are accessible to everyone, including people who use assistive technology such as screen readers. We follow federal accessibility standards and are continuously working to improve the accessibility of records posted on this site.

At the time a record is first posted, it may not yet meet full accessibility standards. For assistance send an e-mail to: OIIFOIAInquiries@fda.hhs.gov and include 508 Accommodation and the title of the document in the subject line of your e-mail. 

How to Request Records Not Listed Here

If you are looking for a record that is not available in this Reading Room, you have the right to request it through FOIA. The Freedom of Information Act gives any member of the public the right to request access to federal agency records. 

To submit a FOIA request online: https://www.accessdata.fda.gov/scripts/foi/FOIRequest/requestinfo.cfm

Note: As of March 12, 2020, FDA asks that all FOIA requests be submitted through the online portal, not by mail, fax, or courier, to ensure your request is logged and processed as quickly as possible.

Have questions about submitting or tracking a FOIA request? Call the Division of Freedom of Information at (301) 796-3900 or visit:

Archived Content

Records in this Reading Room are generally available on this page for five years. After that, FDA begins archiving them, though some may remain posted longer. The absence of a record from this page does not necessarily mean it no longer exists; older records can often be found through the archive link below.

For records from before 2012, visit: https://wayback.archive-it.org/7993/20170404012657/https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/default.htm. 

If you are unable to locate an older record through the archive, contact OII's Division of Information Disclosure Policy at OIIFOIAInquiries@fda.hhs.gov for further assistance.
 


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Record Date Company Name FEI Number Record Type State Country Establishment Type Publish Date Excerpt
Cascade Specialty Pharmacy LLC 3015133983 483 Washington Producer of Non Sterile Drug Products
Annovex Pharma Inc 3020928491 483 Virginia Outsourcing Facility
Fayetteville VA Medical Center 1073803 483 North Carolina Producer of Sterile Drug Products
Denver Solutions LLC dba Leiters Health 3013438582 Untitled Letter Colorado Outsourcing Facility
Lt Col Luke Weather Jr Veterans Affairs Medical Center 1074265 483 Tennessee Producer of Sterile Drug Products
Sincerus Florida, LLC 3012384835 483 Florida Outsourcing Facility
Strides Pharma Science Limited 3004554612 483 India Human Drug Manufacturer
Emcure Pharmaceuticals Limited 301459503 483 India Manufacturer
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
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