1Averaging an out-of-specification result is not an investigation
2020No stability study reports since then
What happened
Microbiological tests on component lots failed for yeast and mold in November 2025.
The firm did not investigate. FDA writes that it "invalidated the OOS results by averaging".
The lots were released and used. A customer later started a Class I recall for potential fungal contamination.
The corrective action did not work. FDA also found annual product reviews missing since 2024.
Check in your QMS
Can anyone close an out-of-specification result without a documented root cause?
Does every CAPA carry an effectiveness check, with a date and a measurable criterion?
Does someone see when an annual product review or a stability report is late?
Letter 320-27-04 to Silgan Dispensing Systems, for its site in Spokane, Washington. It cites 21 CFR 211.192 and 211.22. Read the letter
Since Feb 2025
FDA Warning letter · 6 October 2026
2Your contract laboratory's data is your data
0 CFURecorded on a plate where the investigator found a colony
What happened
A contract laboratory recorded only passing plate counts. Results too numerous to count were left out.
Cracked and dried-out plates were recorded as 0 CFU and discarded without a second review.
The laboratory found that this selective recording went back to February 2025.
FDA rejected its response: it did not say whether certificates sent to customers were affected.
Check in your QMS
Does each of your contract laboratories have a quality agreement and a current audit?
Does that audit look at raw data, or only at certificates of analysis?
If a laboratory reports a data problem, do you record a deviation that names your batches?
Letter 320-27-05 to Eurofins SF Analytical Laboratories, for its site in Horsham, Pennsylvania. It cites 21 CFR 211.194(a), 211.192 and 211.22. Read the letter
Repeat finding
FDA Warning letter · 2 October 2026
3A repeat finding is a CAPA that did not work
"Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate."
FDA, letter 320-27-03
What happened
FDA cited a sterile drug maker for aseptic practice, contamination control and its quality unit.
An earlier warning letter, 320-19-01, had cited similar violations at the same site.
Check in your QMS
When you close a CAPA, does anything check later that the problem has not come back?
Can you list your past inspection observations, each with the CAPA that answered it?
Does management review see repeat deviations and repeat audit findings?
Letter 320-27-03 to Hanlim Pharm, for its site in Yongin, South Korea. It cites 21 CFR 211.113(b), 211.42(c), 211.110(a) and 211.22. Read the letter
Still 2011
EU EU GMP Guide · checked 1 November 2026
4In Europe, Annex 11 and Chapter 4 have not changed yet
2011The versions of Annex 11 and Chapter 4 still in force
What happened
The EU GMP Guide still lists Annex 11 (computerized systems) and Chapter 4 (documentation) in their 2011 versions.
It lists no Annex 22 on artificial intelligence yet.
Drafts of all three were open for public comment from 7 July to 7 October 2025.
Check in your QMS
Your computerized systems are still inspected against the 2011 Annex 11.
Read the drafts now. They show what inspectors will ask for once the new texts apply.
If you use artificial intelligence in a GMP process, list where.