298 FDA drug CGMP warning letters from 2023-11-06 to 2026-10-27: 162 of them (54%) cite problems in this area: identity testing under 21 CFR 211.84, DEG and EG testing of glycerin and other high-risk components, supplier qualification. 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 |
|---|---|---|
| Components released without identity testing (relying on the supplier's CoA) Cross-system How to find it: For each component lot received (ERP): the identity test result in the LIMS before release; flag lots released on the CoA alone, and suppliers whose CoA was never verified. FDA wrote, for example: “No identity testing of each component lot, incl. sorbitol at DEG/EG risk; relied on unverified COAs.” | ERP / inventory, LIMS / CDS | 156 · 52.3% |
| High-risk components not tested for DEG / EG or methanol Cross-system How to find it: For every lot of glycerin, propylene glycol, sorbitol and other high-risk components: the DEG / EG (or methanol) test result in the LIMS before use; flag lots without it. FDA wrote, for example: “No identity testing of each component lot, incl. sorbitol at DEG/EG risk; relied on unverified COAs.” | ERP / inventory, LIMS / CDS | 71 · 23.8% |
| Suppliers not qualified or not on the approved list Cross-system How to find it: For each component lot received: the supplier and manufacturer against the approved supplier list in the QMS; flag unapproved or expired approvals. FDA wrote, for example: “No component identity/specification testing; relied on unverified supplier COAs.” | ERP / inventory, QMS | 62 · 20.8% |
| Components used before release or after their expiry / retest date Cross-system How to find it: For each component dispensed in a batch (MES): its status and expiry / retest date in the ERP at that time; flag quarantined, rejected or expired lots. FDA wrote, for example: “Incoming components were not adequately tested and expired or failing raw material was used.” | MES / eBMR, ERP / inventory | 3 · 1.0% |
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.