298 FDA drug CGMP warning letters from 2023-11-06 to 2026-10-27: 161 of them (54%) cite problems in this area: quality unit oversight, approval of procedures and releases, annual product reviews. 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 |
|---|---|---|
| Quality unit not approving procedures, records and releases Cross-system How to find it: Check that every SOP and master record revision (DMS), every batch release (ERP) and every investigation closure (QMS) was approved by someone in the quality unit (the user list's department / role). FDA wrote, for example: “Quality unit did not adequately review raw material qualification and formulation; color additive records conflict.” | Documents (DMS), QMS, ERP / inventory, MES / eBMR | 150 · 50.3% |
| Procedures missing for required activities How to find it: Compare the plant's effective SOPs (DMS) with the required list (complaints, suppliers, change control, OOS, deviations, cleaning, training, product review…); the plant confirms gaps. FDA wrote, for example: “Inadequate production and process control procedures, incl. system qualification.” | Documents (DMS) | 64 · 21.5% |
| Annual product reviews missing or late Cross-system How to find it: For each product made in the last year (ERP): its annual product review and date; flag products without one or overdue. FDA wrote, for example: “Annual product reviews not completed since 2024.” | QMS, ERP / inventory | 21 · 7.0% |
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.