How this database is built

What's in the record

Last checked: Nov 6, 2026 at 14:26 UTC. Latest FDA posting included: Nov 3, 2026.

1,703 of 3,795 records in the saved FDA index are in scope: drugs, medical devices and biologics. The included letter issue dates start in 2021. Food, cosmetics, tobacco and veterinary letters are outside this product scope.

The dataset includes facilities in the United States and other countries. It is not a complete history of all FDA enforcement or a dataset of every facility inspected.

Extracted facts and assisted readings

Recipient, office, dates, subjects and product tags originate in FDA's records. Rules extract CFR references, explicit ISO 13485 clause references, and finding headings. Bare clause numbers are not assigned to ISO without an explicit standard reference. Top-level descriptions use source excerpts checked against the archived FDA letter. Unchecked model summaries are not published. A source excerpt is a selected passage, not a complete summary. A language model still supplies finding interpretations, categories and requests; some inspection dates and prose findings may also be model-assisted.

Finding excerpts undergo automated normalized text matching. That check does not verify every interpretation, request or category, and the readings may omit findings. Always follow the original FDA letter before relying on an observation.

Search and filters

• Search covers companies, locations, subjects, extracted findings, citations and model-assisted readings, not every word of the original letter.
• Multiple selected quality terms must all match. Within another dimension, such as products or years, a match to any selected value is enough.
• Different dimensions combine to narrow the selection. A keyword match is not the same as a model-assigned issue type.
• Shared links preserve filters and citation mode. Moving between the tabs keeps that context.

How to read the charts

• Section, clause and category counts represent letters, counted once in each category. One letter may contribute to multiple categories.
• Findings only uses citations attached to extracted findings; All citations also includes citations elsewhere in the letter, including background references. Regulation pages and the Letters filter count all citations.
• Monthly charts use issue dates. The latest period is partial; publication can lag issue date. Year-to-date comparisons use matching calendar windows.
• These counts do not estimate industry-wide prevalence, risk or inspection rates. No denominator of all facilities or inspections is present.

Response windows and close-outs

Response windows are extracted from explicit response instructions in the archived letter. Ambiguous windows are marked unverified rather than inheriting an unrelated deadline. A window measured from receipt is not a calendar due date because the receipt date is unknown.

No published close-out does not mean a company is currently out of compliance. FDA notes that later interactions can change the status of the issues described.

Historical device regulations

QMSR took effect February 2, 2026. Historical Part 820 text is labeled and dated. ISO clause references are shown separately, with short titles but no reproduced standard text. Related device citations are grouped using Botable’s versioned topic map (2026-09-29.1). Topics are not one-to-one regulatory equivalents. Each letter counts once per topic in the selected citation mode, and may count in more than one topic. Paragraph-ambiguous and broad citations remain in General. New-only topics and groups with changed coverage show counts without growth rankings. Exact citations remain available. Changed citation patterns should not be interpreted as evidence that a problem disappeared.

Updates

This database uses a validated data snapshot, not a real-time feed. The date and time it was last checked appear at the top of every page.