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FDA 483s and warning letters that could have been avoided

With Atto Pharma eBMR, Atto eLogbooks and Atto QMS: every finding FDA cited, and the control that prevents it.

Every week FDA posts warning letters to drug manufacturers. Most follow an inspection whose observations were first listed on a Form FDA 483. We take one letter at a time, from FDA's own published text: each finding, why it happens, how plants prevent it, and which Atto Pharma module does that. Two a day, newest letters first.

What FDA cites most, in figures · by area, by 21 CFR 211 section, by system · find these problems in your own records

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See these controls on your own batch records

Atto Pharma eBMR, Atto eLogbooks and Atto QMS: limits checked as values are entered, electronic signatures and audit trails, investigations and CAPA that follow your SOPs. Built for 21 CFR Part 11 and EU GMP Annex 11.

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The weekly FDA digest

FDA's warning letters, finding by finding, every Monday

Each week's letters to drug manufacturers: what FDA cited, why plants run into it, and the control that prevents it. One email a week, free.

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