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Enforcement Weekly.
The week's FDA and EU enforcement, summarized for you.
Every Thursday: the warning letters FDA's drug, biologics and device centers posted that week, the Form 483s FDA released, and the EU/EEA GMP non-compliance reports entered in EudraGMDP. Each is summarized from its own text and linked to the source.
- 01What stood out. A short read of the week: the kinds of problems, the regulations cited most, and firms with an earlier record.
- 02Companies to note, chosen by fixed rules and shown with the reason: an earlier enforcement record, an import alert, data integrity, sterile manufacturing or 21 CFR Part 11.
- 03Regulations cited most: the 21 CFR sections cited this week, beside the 12 weeks before.
- 04Every record, linked. A short summary of each, with the sections it cites and a link to FDA's or EudraGMDP's own copy.
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What each newsletter covers
Warning letters from FDA's drug (CDER), biologics (CBER) and device (CDRH) centers; Form 483s and inspection reports FDA posts in its FOIA Electronic Reading Room; and GMP non-compliance reports entered in the EU/EEA EudraGMDP register. Warning letters on food, tobacco and veterinary products are not covered. Letters to online sellers of unapproved drugs, and 483s from inspections more than a year old, are listed by name.
How each newsletter is made
The lists, counts and citations come straight from the records. A short summary of each record is written by AI from that record's text and checked against it (its quotes, the sections it names and its figures), then an editor reviews the newsletter before it is sent. A newsletter says "all" only when every source has been checked and nothing is left to add.
When it arrives
Every Thursday. It covers the records posted from Wednesday to the following Tuesday, so FDA's Tuesday postings are in it. A letter FDA posts weeks after its date appears in the next newsletter.
What it is not
Legal or regulatory advice. A warning letter, 483 or non-compliance report describes one firm at one time, and the firm's status may have changed since. Read the source before relying on a summary.
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From the team behind RegLens
RegLens holds these records beside the regulations they cite, so you can ask what regulators have said about a clause and read the letters that say it. See RegLens Enforcements ↗