21 CFR Part 211 · Current Good Manufacturing Practice for Finished Pharmaceuticals

§ 211.28 Personnel responsibilities

Subpart B - Organization and Personnel Official text on eCFR Amendment history

(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.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 211.28

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).

  • Clothing appropriate for duties performed 155
  • Protective Apparel Not Worn 117
  • Habits of good sanitation & health 30
  • Unauthorized Personnel in Limited Access Areas 8
  • Excluding Employees with Illness, Lesions 1

Warning letters citing § 211.28

25 FDA warning letters since 2017 cite this section ; the most recent:

FDA guidance that cites § 211.28

Amendment history

Federal Register documents that created or amended this section.