21 CFR 211.25
Personnel qualifications
21 CFR 211.25 is the regulation titled “Personnel qualifications” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 23 FDA warning letters have cited it.
- Letters citing it
- 23 since 2021
- Jan 1 to Oct 30, 2026
- 6 against 6 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 20 letters
- Closed out
- 0% 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.
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.25 most often, as written in the letters.
- 4 lettersYour firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to…
- 1 letterYour firm failed to ensure that each person engaged in the manufacture, processing, packing, or holding of a drug product has the education, training, and experience, or any combination thereof, to enable that person to…
- 1 letterYour firm failed to ensure that each person responsible for supervising the manufacture, processing, packing, or holding of a drug product has the education, training or experience, or any combination thereof, to…
The regulation
Read the text of 21 CFR 211.25 (eCFR, as of Sep 1, 2026)
(a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the current good manufacturing practice regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in current good manufacturing practice shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
(b) Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.
(c) There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.25.
- 21 CFR 211.22Responsibilities of quality control unit20 letters cite both
- 21 CFR 211.100Written procedures; deviations18 letters cite both
- 21 CFR 211.165Testing and release for distribution17 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures17 letters cite both
- 21 CFR 211.192Production record review12 letters cite both
- 21 CFR 211.166Stability testing9 letters cite both
- 21 CFR 211.188Batch production and control records9 letters cite both
- 21 CFR 211.137Expiration dating7 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.25 that FDA posted most recently.
- DrugsView Pritam International Private LimitedBrush Buddies Cookies 'n Cream Ice Cream Flavored ToothpasteIssuedOct 27, 2026PostedNov 3, 2026
- DrugsView Pine Pharmaceuticals, LLCsterile compounded drug productsIssuedAug 7, 2026PostedOct 6, 2026
- DrugsView Suretec Innovations, LLCOTC sanitizing wipes and hand sanitizersIssuedAug 13, 2026PostedAug 18, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.