298 FDA drug CGMP warning letters from 2023-11-06 to 2026-10-27: 131 of them (44%) cite problems in this area: processes not validated, no ongoing process verification, batch sizes and equipment outside the validated state. 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 |
|---|---|---|
| Products made with no process validation Cross-system How to find it: List the product, batch size and equipment train of every batch (MES), and check each combination against a process validation report (DMS); flag those not covered. FDA wrote, for example: “Inadequate production and process control procedures, incl. system qualification.” | MES / eBMR, Documents (DMS) | 128 · 43.0% |
| No ongoing process verification (no trending of batch data) How to find it: Trend critical parameters and results across batches; flag shifts and drifts, and products with no trend review in the last year. FDA wrote, for example: “A (redacted) system supplying a drug component was not qualified or monitored and process validation was lacking.” | MES / eBMR, LIMS / CDS | 22 · 7.4% |
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.