21 CFR 211.28: Personnel responsibilities
Requires drug manufacturing personnel to wear clean, appropriate protective clothing, practice good hygiene, enter limited-access areas only with authorization, and be excluded from product contact when ill or having open lesions, reporting such conditions.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart B, Organization and Personnel
1%
of drug-manufacturing 483s since 2023 cite this section at least once
How FDA words it
The opening lines investigators use most when they cite 211.28, from the 483s we hold.
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.Most used
Protective apparel is not worn as necessary to protect drug products from contamination.211.28(a)
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.211.28(a)
Cited over time
483s citing 211.28, by yearMost citations in 2017. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2017.
Recent 483s citing 211.28
- Greenwich Rx · Tomball, TexasPersonnel donned gowning apparel improperly, in a way that may have caused the… Sep 9, 2026
- Houston Rx LLC · Houston, TexasPersonnel performed aseptic manipulations with exposed hair or skin… Aug 28, 2026
- Lt Col Luke Weather Jr Veterans Affairs · Memphis, TennesseePersonnel perfoimed aseptic manipulations with exposed hair or skin… Jun 4, 2026
- Turbare Manufacturing · Conway, ArkansasProduction personnel were not practicing good sanitation and health habits… May 7, 2026
- JKR Pharmacy Ventures, LLC dba Doc · Lexington, KentuckyClothing of personnel engaged in the manufacturing, processing, packing and holding… Dec 19, 2025
The regulation text
§ 211.28 Personnel responsibilities.
(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.
Questions
What does 21 CFR 211.28 require?
Requires drug manufacturing personnel to wear clean, appropriate protective clothing, practice good hygiene, enter limited-access areas only with authorization, and be excluded from product contact when ill or having open lesions, reporting such conditions.
How often is 211.28 cited in Form 483s?
It appears in about 1% of the drug-manufacturing 483s we hold from 2023 onward.
How do FDA investigators word a 211.28 observation?
The most common opening is: “Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.”
Which sections are cited alongside 211.28?
In the same 483s, investigators most often also cite 211.113 (Control of microbiological contamination), 211.42 (Design and construction features), 211.166 (Stability testing), 211.192 (Production record review).