21 CFR 106.10: Controls to prevent adulteration by workers
Manufacturers must employ enough qualified, supervised personnel, ensure workers practice good hygiene (clean garments, protective apparel, handwashing), and exclude ill or infected workers from contact with formula, materials, and equipment until cleared.
Part 106, Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications · Subpart B, Current Good Manufacturing Practice
Recent 483s citing 106.10
- Abbott Laboratories dba Abbott Nutrition · Sturgis, MichiganPersonnel working directly with infant formula, its raw materials, packaging, or… Mar 18, 2022
- Abbott Nutrition · Sturgis, MichiganPersonnel working directly with infant formula, its raw materials, packaging, or… Sep 24, 2021
The regulation text
§ 106.10 Controls to prevent adulteration by workers.
(a)A manufacturer shall employ sufficient personnel, qualified by education, training, or experience, to perform all operations, including all required recordkeeping, in the manufacture, processing, packing, and holding of each infant formula and to supervise such operations to ensure that the operations are correctly and fully performed.
(b)Personnel working directly with infant formula, infant formula raw materials, infant formula packaging, or infant formula equipment or utensil contact surfaces shall practice good personal hygiene to protect the infant formula against contamination. Good personal hygiene includes:
(1)Wearing clean outer garments and, as necessary, protective apparel such as head, face, hand, and arm coverings; and
(2)Washing hands thoroughly in a hand washing facility with soap and running water at a suitable temperature before starting work, after each absence from the work station, and at any other time when the hands may become soiled or contaminated.
(c)Any person who reports that he or she has, or appears by medical examination or supervisory observation to have, an illness, open lesion (including boils, sores, or infected wounds), or any other source of microbial contamination that creates a reasonable possibility that the safety of an infant formula may be adversely affected, shall be excluded from direct contact with ingredients, containers, closures, in-process materials, equipment, utensils, and infant formula product until the condition is corrected or determined by competent medical personnel not to jeopardize the safety of the infant formula.
Questions
What does 21 CFR 106.10 require?
Manufacturers must employ enough qualified, supervised personnel, ensure workers practice good hygiene (clean garments, protective apparel, handwashing), and exclude ill or infected workers from contact with formula, materials, and equipment until cleared.
Which sections are cited alongside 106.10?
In the same 483s, investigators most often also cite 106.30 (Controls to prevent adulteration caused by equipment or utensils), 106.20 (Controls to prevent adulteration caused by facilities), 106.55 (Controls to prevent adulteration from microorganisms).