298 FDA drug CGMP warning letters from 2023-11-06 to 2026-10-27: 72 of them (24%) cite problems in this area: people working on SOP revisions they weren't trained on, expired training, analysts and aseptic operators without qualification. Below, each problem FDA cites, how often, where the records that show it live, and how a plant can find it in its own records.
What FDA cites
| Problem | Records in | Letters |
|---|---|---|
| A new SOP revision effective before the people using it were trained Cross-system How to find it: For each SOP revision: its effective date (DMS) against the training completion of every person in the roles that use it (TMS); flag revisions made effective with people untrained. FDA wrote, for example: “Redacted procedure/material not shown suitable for intended use.” | Documents (DMS), Training (TMS / LMS) | 40 · 13.4% |
| Analysts or aseptic operators working without their qualification Cross-system How to find it: Flag tests run by analysts without the method qualification, and aseptic or cleanroom work by people whose gowning qualification had lapsed. FDA wrote, for example: “Inadequate aseptic/sterilization procedures, operator practices and smoke studies.” | LIMS / CDS, Training (TMS / LMS), MES / eBMR | 36 · 12.1% |
| Training expired or overdue when the work was done Cross-system How to find it: Flag every batch step, logbook entry or test done by someone whose required training or qualification had expired that day. FDA wrote, for example: “Micro lab training did not evaluate competency.” | MES / eBMR, LIMS / CDS, Training (TMS / LMS) | 12 · 4.0% |
| Steps signed by people not trained on the current SOP or master record Cross-system How to find it: For each signed step: the SOP or master record revision it followed (DMS), and the signer's training on that revision (TMS) — flag signatures with no training, or training on an older revision only. FDA wrote, for example: “Micro lab training did not evaluate competency.” | MES / eBMR, Training (TMS / LMS), Documents (DMS) | 11 · 3.7% |
Read the warning letters, one by one · All the figures
Other areas
How these figures are made: Siddhi LLC reads FDA's public drug CGMP warning letters (on fda.gov, 2023-11-06 to 2026-10-27: 298 letters, 1315 findings) and groups each finding by the problem it describes, from the CFR section FDA cites and FDA's wording. A letter counts once in an area, and can count in several areas. These are our grouping of FDA's letters, not FDA's own statistics. The systems are where a plant keeps the records that show each problem: FDA cites the regulation, not a system. Updated with each new release of the Atto Audit Library.
Find these problems in your own records before an inspector does
The Atto Auditor compares the exports of your MES, QMS, LIMS, training, documents, logbooks and ERP, whichever vendors made them, and gives your plant's Audit fit summary: each problem FDA cites, with the records that show it.