298 FDA drug CGMP warning letters from 2023-11-06 to 2026-10-27: 102 of them (34%) cite problems in this area: water systems not monitored, EM excursions not investigated, aseptic processing controls. 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 |
|---|---|---|
| Aseptic processing controls (media fills, interventions, airflow) How to find it: List aseptic interventions recorded in batches (MES) against those qualified in the last media fills (LIMS / DMS); the plant confirms airflow studies. FDA wrote, for example: “Inadequate procedures to prevent microbial contamination of sterile products.” | MES / eBMR, LIMS / CDS, Documents (DMS) | 53 · 17.8% |
| Water system out of limits without investigation, or not monitored Cross-system How to find it: Flag water results over alert / action limits with no investigation, and sampling points missed against the schedule. FDA wrote, for example: “Water system design and control deficiencies.” | LIMS / CDS, QMS | 45 · 15.1% |
| Environmental monitoring excursions not investigated Cross-system How to find it: Match every EM excursion to the batches made in that room that day (MES) and to its investigation (QMS); flag excursions without one, or whose batches were released untouched. FDA wrote, for example: “Inadequate procedures to prevent microbial contamination of sterile products.” | Environmental monitoring, LIMS / CDS, QMS, MES / eBMR | 39 · 13.1% |
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.