298 FDA drug CGMP warning letters from 2023-11-06 to 2026-10-27: 172 of them (58%) cite problems in this area: batch records incomplete at release, batches released with open deviations or without all tests, master record revisions. 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 |
|---|---|---|
| Batches released without all required tests Cross-system How to find it: For each released batch: the product's specification (tests required) against the approved results in the LIMS; flag missing, pending or failed tests at the release date. FDA wrote, for example: “No adequate release or microbial testing of finished batches.” | ERP / inventory, LIMS / CDS | 98 · 32.9% |
| Batch records incomplete when the batch was released Cross-system How to find it: For each released batch: missing steps, signatures or readings in the MES, and the release date in the ERP or QMS before the record was complete. FDA wrote, for example: “Quality unit failed to ensure complete batch records and stability data.” | MES / eBMR, QMS, ERP / inventory | 53 · 17.8% |
| Batches made on a master record or SOP revision that wasn't effective Cross-system How to find it: For each batch: the master record (MBR) and SOP revisions it used against the revisions effective on its manufacturing date in the DMS; flag superseded or not-yet-effective revisions. FDA wrote, for example: “Redacted procedure/material not shown suitable for intended use.” | MES / eBMR, Documents (DMS) | 38 · 12.8% |
| Yields and process limits outside range with no deviation Cross-system How to find it: List every yield, in-process result or parameter outside its limit in the MES, and look for the matching deviation in the QMS (same batch, same step, within days); flag those with none. FDA wrote, for example: “Cleaning carryover limit not justified.” | MES / eBMR, QMS | 28 · 9.4% |
| Batches released with an open deviation, OOS or CAPA Cross-system How to find it: For each released batch, flag deviations, OOS investigations or change controls on it that were still open (or opened later about it) at release. FDA wrote, for example: “Quality unit failed to oversee operations, data integrity and release.” | ERP / inventory, QMS, LIMS / CDS | 16 · 5.4% |
| Hold times exceeded between steps How to find it: Measure the time between the steps that have a hold-time limit and flag batches over it. FDA wrote, for example: “Process and cleaning validation, hold time and stability studies were inadequate.” | MES / eBMR | 4 · 1.3% |
| No batch numbers or traceability across systems Cross-system How to find it: Match batch numbers across the MES, ERP, LIMS and QMS; flag batches found in one system and not the others, and quantities that don't reconcile. FDA wrote, for example: “Same batch number assigned to different products.” | MES / eBMR, ERP / inventory, LIMS / CDS, QMS | 2 · 0.7% |
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.