FDA warning letters tracker

Every FDA warning letter and untitled letter we track that involves telehealth companies, compounding pharmacies, outsourcing facilities or sellers of GLP-1 drugs and peptides — with the letter itself, the company’s response and any close-out.

No letters yet. Records appear here as soon as they are verified.

Methodology

Data sources

FDA warning letters database
FDA untitled letters and notices of violation
Company statements — responses published by recipients or sent to our newsroom

What we include

Warning letters and untitled letters that FDA has posted publicly and that involve telehealth platforms, 503A compounding pharmacies, 503B outsourcing facilities, GLP-1 drugs or peptides.
Each letter is dated by the issue date printed on it; the posting date is recorded separately when it differs.
A letter is listed as soon as we verify it. Its record page is indexed by search engines only after staff write a plain-English summary.

How we verify

Every record is checked against the letter on FDA.gov, and we keep an archived copy when FDA posts a PDF.
We ask each recipient for comment and add a public response or an FDA close-out letter when one exists.

Known gaps

FDA often posts letters days or weeks after issuing them, so the newest letters may be missing.
FDA does not always post close-out letters. A blank close-out date does not mean the matter is unresolved.
Letters are allegations at the time they were issued, not findings that the law was violated.

Update frequency: Updated when FDA posts new letters; we check FDA’s postings at least weekly.

CSV columns (27)

The CSV file is UTF-8 (with a byte-order mark for Excel), comma-separated with CRLF line endings (RFC 4180), one row per record, with these columns in order. Dates are YYYY-MM-DD (U.S. Eastern); list values are separated by semicolons.

record_url: Permanent record page on this site.
title: Record title.
action_type: Action type code (e.g. warning-letter, recall, fr-rule, approval).
agency: Issuing agency (FDA, DEA, CMS, HHS, FTC, DOJ, state-board, other).
issued_date: Date on the document (YYYY-MM-DD, U.S. Eastern).
posted_date: Date the agency posted it publicly, when different.
effective_date: Effective date (rules and policy changes).
comments_close_date: Public comment deadline (proposed rules).
status: Record status code (open, proposed, final, effective, delayed, vacated, closed-out).
recipient: Company or organization the action names (letters, recalls, approvals).
recipient_url: Profile page of the recipient on this site.
subject: Short product or company label.
products: Drugs and peptides named in the action, separated by semicolons.
subjects: Violation or topic categories, separated by semicolons.
status_labels: Status Label codes shown on the page, separated by semicolons.
fr_document_number: Federal Register document number.
docket_id: Regulations.gov docket ID.
rin: Regulation Identifier Number.
recall_number: FDA recall event number.
recall_class: FDA recall class (I, II or III).
source_url: The agency’s own document.
archived_url: Our archived copy of the document, when available.
company_response: Public company response, as summarized by our staff.
company_response_url: Link to the company’s response.
closeout_date: Date of the agency’s close-out letter, if any.
summary: Staff-written plain-English summary (blank until written).
last_updated: When this record last changed (ISO 8601).