21 CFR 211.56: Sanitation
Requires drug facilities to be kept clean and vermin-free, with followed written procedures assigning sanitation responsibility, cleaning methods and pest-control agent use that prevent contamination, applying equally to contractors and temporary staff.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart C, Buildings and Facilities
5%
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 211.56, from the 483s we hold.
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.Most used
Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.211.56(a)
Non-microbial contamination was observed in your production area.
Cited over time
483s citing 211.56, by yearMost citations in 2022. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2022.
Recent 483s citing 211.56
- RC Outsourcing, LLC · Lowellville, OhioThere is a lack of written procedures assigning responsibility, providing cleaning… Sep 3, 2026
- Carolina Infusion, LLC · Ridgeland, South CarolinaThe Cleanroom areas contain dust-collecting overhangs without adequate and frequent… Aug 18, 2026
- Fujifilm Diosynth Biotechnologies USA Inc. · Research Triangle Park, North CarolinaFacility design and procedural controls for manufacturing drug substance intended… Mar 27, 2026
- Ve t erinary Pharmacy Corporation · Saint Peter, MinnesotaContamination was observed in your production area and areas adjacent to production… Mar 19, 2026
- SCA Phar maceutical s , LLC · Windso r, ConnecticutWritten procedures are not established and followed for the cleaning and… Mar 13, 2026
The regulation text
§ 211.56 Sanitation.
(a)Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals). Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner.
(b)There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; such written procedures shall be followed.
(c)There shall be written procedures for use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be followed. Rodenticides, insecticides, and fungicides shall not be used unless registered and used in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135).
(d)Sanitation procedures shall apply to work performed by contractors or temporary employees as well as work performed by full-time employees during the ordinary course of operations.
Questions
What does 21 CFR 211.56 require?
Requires drug facilities to be kept clean and vermin-free, with followed written procedures assigning sanitation responsibility, cleaning methods and pest-control agent use that prevent contamination, applying equally to contractors and temporary staff.
How often is 211.56 cited in Form 483s?
It appears in about 5% of the drug-manufacturing 483s we hold from 2023 onward.
How do FDA investigators word a 211.56 observation?
The most common opening is: “Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.”
Which sections are cited alongside 211.56?
In the same 483s, investigators most often also cite 211.67 (Equipment cleaning and maintenance), 211.113 (Control of microbiological contamination), 211.192 (Production record review), 211.42 (Design and construction features).