21 CFR 211.34
Consultants
21 CFR 211.34 is the regulation titled “Consultants” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 8 FDA warning letters have cited it.
- Letters citing it
- 8 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 5 letters
- Closed out
- 13% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
The regulation
Read the text of 21 CFR 211.34 (eCFR, as of Sep 1, 2026)
Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.34.
- 21 CFR 211.22Responsibilities of quality control unit5 letters cite both
- 21 CFR 211.192Production record review4 letters cite both
- 21 CFR 201.128Meaning of “intended uses”3 letters cite both
- 21 CFR 211.100Written procedures; deviations3 letters cite both
- 21 CFR 211.160General requirements2 letters cite both
- 21 CFR 211.165Testing and release for distribution2 letters cite both
- 21 CFR 211.166Stability testing2 letters cite both
- 21 CFR 211.180General requirements2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.34 that FDA posted most recently.
- DrugsView GC America, Inc.OTC drug productsIssuedMay 14, 2026PostedMay 26, 2026
- DrugsView Eugia Pharma Specialities LimitedSterile injectable drug productsIssuedAug 15, 2024PostedAug 20, 2024
- DrugsView Kobayashi Healthcare International, Inc.ZIM'S HYDRO COOLING PAIN RELIEF PATCHIssuedJan 27, 2023PostedJan 31, 2023
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Counts include every citation in a letter, as the Letters filter does. How this database is built.