Discover our comprehensive & searchable FDA enforcement letter database

Start a free trial of the FDA Enforcement Module to explore the database

Thompson FDA's unique FDA Enforcement Letter Database includes FDA Warning Letters, Untitled Letters, Cyber Letters and OHRP Determination Letters dating back over 40 years and lets you:

Get an inside view of how to solve your compliance issues — Easily find out how the FDA has evaluated companies’ specific issues and reacted to their proposed solutions.
Follow current trends in FDA enforcement — Keep up to date on the agency’s current enforcement priorities and its compliance concerns for companies like yours.
Pinpoint the FDA’s views on how to comply with specific statutes and regulations — Search by specific U.S. Code or Code of Federal Regulations section numbers.

Plus, Thompson’s FDA Enforcement Letter Database is easier to use, offers more ways to search, and produces more search results than the FDA’s Warning Letter database.

Superior Coverage

The database includes all FDA Warning Letters, Untitled Letters, and Cyber Letters — plus Determination Letters issued by the U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) — dating back to July 1982.

One Central Location

The FDA archives its past Warning Letters — meaning that letters before a certain date are no longer available through the agency’s search function.
FDA Untitled Letters — including important Untitled Letters issued by the agency’s Office of Prescription Drug Promotion (OPDP) dealing with the advertising and promotion of human prescription drugs — are scattered over many other locations on the FDA’s website.
Thompson’s FDA Enforcement Letter Database allows searching for all these letters — and all other FDA enforcement letters — using a single interface.

Advance Search Capability

Thompson’s FDA Enforcement Letter Database’s advanced search engine offers more ways to search, including:

Letter text
Letter date — on, before or after a specific date, or during a range of dates
Issuer name — the specific FDA component that issued the letter
Recipient company — the specific company name, or any words within the name
Product category — narrowing your search to one of 13 product types
Regulatory topic — letting you focus your search on your particular issue
Alleged violation — providing a summary of the agency’s allegations
Product name — brand name or product type
Letter type — Warning Letter, Untitled Letter, Cyber Letter or Determination Letter