298 FDA drug CGMP warning letters from 2023-11-06 to 2026-10-27: 111 of them (37%) cite problems in this area: no ongoing stability programme under 21 CFR 211.166, missed pulls, stability OOS not investigated, expiry dates not supported. 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 |
|---|---|---|
| No ongoing stability programme for products on the market Cross-system How to find it: For each product and pack sold in the last year (ERP): a stability study with a batch on test in the LIMS; flag products and packs without one, and expiry dates longer than the data supports. FDA wrote, for example: “No adequate ongoing stability program.” | ERP / inventory, LIMS / CDS | 104 · 34.9% |
| Stability pulls missed or tested late How to find it: Compare each stability time point's due date with when it was pulled and tested; flag missed and late ones. FDA wrote, for example: “No adequate ongoing stability program.” | LIMS / CDS | 88 · 29.5% |
| Stability OOS or trends not investigated Cross-system How to find it: Flag stability results out of specification or trending towards it (out of trend) with no investigation in the QMS. FDA wrote, for example: “Viscosity OOS on stability not investigated; weak CAPA.” | LIMS / CDS, QMS | 17 · 5.7% |
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.