21 CFR 211.52: Washing and toilet facilities
Requires drug manufacturers to provide adequate washing facilities with hot and cold water, soap or detergent, and air driers or single-service towels, plus clean toilet facilities easily accessible to working areas.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart C, Buildings and Facilities
How FDA words it
The opening lines investigators use most when they cite 211.52, from the 483s we hold.
Washing and toilet facilities lack hot and cold water.Most used
Cited over time
483s citing 211.52, 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 211.52
- CoreRX Inc. DBA Bend Bioscience · Clearwater, FloridaWashing and toilet facilities lack hot and cold water, soap or detergent, air… Feb 26, 2026
- KENIL HEALTHCARE PRIVATE LIMITED · Mehsana, IndiaBuildings used in the manufacturing of Intermediates and finished APIs are not… Dec 11, 2024
- PINNACLE LIFE SCIENCE PRIVATE LIMITED · Solan, Himachal Pradesh, IndiaBuildings used in the manufacturing, processing, packing, and holding of a drug… Apr 22, 2024
- Jiangsu Hengrui Pharmaceuticals Co., Ltd · Lianyungang, Jiangsu, ChinaWashing and toilet facilities lack hot and cold water… Jan 16, 2024
- Products by O2, Inc. · Fort Lauderdale, FloridaWashing and toilet facilities lack hot and cold water… Oct 23, 2023
The regulation text
§ 211.52 Washing and toilet facilities.
Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily accesible to working areas.
Questions
What does 21 CFR 211.52 require?
Requires drug manufacturers to provide adequate washing facilities with hot and cold water, soap or detergent, and air driers or single-service towels, plus clean toilet facilities easily accessible to working areas.
How do FDA investigators word a 211.52 observation?
The most common opening is: “Washing and toilet facilities lack hot and cold water.”
Which sections are cited alongside 211.52?
In the same 483s, investigators most often also cite 211.160 (General requirements), 211.68 (Automatic, mechanical, and electronic equipment), 211.113 (Control of microbiological contamination), 211.192 (Production record review).