21 CFR 211.28
Personnel responsibilities
21 CFR 211.28 is the regulation titled “Personnel responsibilities” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 5 FDA warning letters have cited it.
- Letters citing it
- 5 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 200.10, in 5 letters
- Closed out
- 20% 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 211.28 most often, as written in the letters.
- 5 lettersYour firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a))
- 2 lettersYour firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic…
- 1 letterYour firm failed to conduct laboratory testing to determine whether each batch of drug product purporting to be sterile and pyrogen-free conforms to such requirements (21 CFR 211.167(a))
The regulation
Read the text of 21 CFR 211.28 (eCFR, as of Sep 1, 2026)
(a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
(b) Personnel shall practice good sanitation and health habits.
(c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas.
(d) Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.28.
- 21 CFR 200.10Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers5 letters cite both
- 21 CFR 201.115New drugs or new animal drugs5 letters cite both
- 21 CFR 210.1Status of current good manufacturing practice regulations5 letters cite both
- 21 CFR 211.113Control of microbiological contamination5 letters cite both
- 21 CFR 211.42Design and construction features5 letters cite both
- 21 CFR 211.192Production record review3 letters cite both
- 21 CFR 211.100Written procedures; deviations2 letters cite both
- 21 CFR 211.166Stability testing2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.28 that FDA posted most recently.
- DrugsView Apothecary Pharma, LLCTirzepatide 10 mg/mLIssuedDec 1, 2025PostedMar 17, 2026
- DrugsView ProRx, LLCsterile drug productsIssuedMar 4, 2025PostedMar 4, 2025
- DrugsView US Specialty Formulations, LLCB-Complex plus Chromic Chloride 30 mL, Sarracenia Purpurea 0.17 g/mL, medroxyprogesteroneIssuedJul 26, 2023PostedAug 8, 2023
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Counts include every citation in a letter, as the Letters filter does. How this database is built.