298 FDA drug CGMP warning letters from 2023-11-06 to 2026-10-27: 118 of them (40%) cite problems in this area: inadequate investigations under 21 CFR 211.192, CAPA that doesn't work, changes made without change control. 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 |
|---|---|---|
| Investigations inadequate: root cause, scope and other batches not covered Cross-system How to find it: For each deviation about equipment, a material lot or a process step: the other batches that used the same equipment, lot or step in the period (MES), against the batches the investigation lists; flag those left out. FDA wrote, for example: “Inadequate investigation of visual inspection failures; batches shipped to US.” | QMS, MES / eBMR | 89 · 29.9% |
| CAPA not effective: the same problem keeps coming back Cross-system How to find it: Group deviations by root cause, equipment, product and step; flag repeats within 12 months after a CAPA was closed, and CAPAs closed without an effectiveness check. FDA wrote, for example: “Repeat violations previously discussed at December 2023 regulatory meeting.” | QMS, MES / eBMR | 37 · 12.4% |
| Complaints not investigated or not linked to batches Cross-system How to find it: For each complaint: the batch named, its investigation, and the batch record reviewed; flag complaints closed without either. FDA wrote, for example: “No QU procedures for complaints, release testing, change control, cleaning, deviations.” | QMS, MES / eBMR | 15 · 5.0% |
| Changes made without change control Cross-system How to find it: For each new SOP or master record revision (DMS) and each changed recipe or equipment configuration (MES): the approved change control in the QMS; flag revisions effective without one, or before it was approved. FDA wrote, for example: “Process parameters changed without change control.” | Documents (DMS), MES / eBMR, QMS | 13 · 4.4% |
| Deviations and CAPAs open beyond their due dates How to find it: Flag deviations and CAPAs past their due dates, extended more than once, or closed with actions still open. FDA wrote, for example: “Leaking bag complaints not investigated; inadequate CAPA delayed recall.” | QMS | 5 · 1.7% |
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.