298 FDA drug CGMP warning letters from 2023-11-06 to 2026-10-27: 62 of them (21%) cite problems in this area: cleaning between products, clean hold times, cleaning verification, calibration overdue under 21 CFR 211.67 and 211.68. 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 |
|---|---|---|
| Equipment used without a valid cleaning (between products, or clean hold expired) Cross-system How to find it: For each batch: the last cleaning of each piece of equipment before use (logbook), its type (between products / same product), and the clean hold time; flag uses with no cleaning, the wrong type, or an expired hold. FDA wrote, for example: “Equipment not cleaned/sanitized; ISO 5 cleaning documented but not done.” | MES / eBMR, eLogbooks / CMMS | 58 · 19.5% |
| Cleaning procedures not validated for the products and equipment used How to find it: List product-equipment pairs actually used (MES) and check each is covered by a validated cleaning procedure; the plant confirms the coverage. FDA wrote, for example: “Cleaning procedures not validated.” | Documents (DMS), MES / eBMR | 33 · 11.1% |
| Cleaning verification failed or missing (swab or rinse results) Cross-system How to find it: Match each cleaning that needs verification to its swab / rinse results in the LIMS; flag missing or failed results, and failed ones with no deviation. FDA wrote, for example: “Non-dedicated filling equipment was not adequately cleaned, leaving product residue.” | eLogbooks / CMMS, LIMS / CDS, QMS | 29 · 9.7% |
| Equipment used while under maintenance or not released Cross-system How to find it: Flag every batch step that used equipment whose logbook showed it under maintenance, breakdown or not released at that time. FDA wrote, for example: “A (redacted) system storage tank had biofilm and gross contamination and unsanitary repairs.” | MES / eBMR, eLogbooks / CMMS | 6 · 2.0% |
| Logbooks missing for days the equipment was used Cross-system How to find it: Compare the days each piece of equipment was used in batches (MES) with its logbook entries; flag days with use and no entry. FDA wrote, for example: “Cleaning procedures lacking; cleaning logs missing; high-bioburden cleaning material.” | MES / eBMR, eLogbooks / CMMS | 5 · 1.7% |
| Equipment used while calibration was overdue Cross-system How to find it: For each equipment use in a batch or test: the calibration due date in the logbook or CMMS; flag uses after it was due. FDA wrote, for example: “Laboratory controls such as calibrated equipment were lacking.” | MES / eBMR, eLogbooks / CMMS, LIMS / CDS | 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.