21 CFR 211.48: Plumbing
Requires potable water meeting EPA drinking water standards, supplied under continuous positive pressure through a defect-free plumbing system, and adequately sized drains with air breaks or mechanical devices to prevent back-siphonage.
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 211.48, from the 483s we hold.
The plumbing system contains defects that could contribute to the contamination of drug products.Most used
Cited over time
483s citing 211.48, by yearMost citations in 2019. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2019.
Recent 483s citing 211.48
- Noble Panacea Labs, Inc · Irvine, CaliforniaThe plumbing system contains defects that could contribute to the contamination of… Nov 8, 2024
- Natural Technology LLC dba NaturTech LLC · Terrell, TexasThe plumbing system contains defects that could contribute to the contamination of… Mar 1, 2024
- CELLTRION Inc · Incheon, South KoreaYour Quality Unit is not fully exercising its authority and/or responsibilities to… Feb 27, 2024
- SHILPA MEDICARE LIMITED · Jadcherla, Telangana, IndiaThe plumbing system contains defects that could contribute to the contamination of… Nov 9, 2023
- RUBICON RESEARCH LIMITED · Satara, Maharashtra, IndiaThe plumbing system contains defects that could contribute to the contamination of… Jan 27, 2023
The regulation text
§ 211.48 Plumbing.
(a)Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. Potable water shall meet the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations set forth in 40 CFR part 141. Water not meeting such standards shall not be permitted in the potable water system.
(b)Drains shall be of adequate size and, where connected directly to a sewer, shall be provided with an air break or other mechanical device to prevent back-siphonage.
[43 FR 45077, Sept. 29, 1978, as amended at 48 FR 11426, Mar. 18, 1983]
Questions
What does 21 CFR 211.48 require?
Requires potable water meeting EPA drinking water standards, supplied under continuous positive pressure through a defect-free plumbing system, and adequately sized drains with air breaks or mechanical devices to prevent back-siphonage.
How do FDA investigators word a 211.48 observation?
The most common opening is: “The plumbing system contains defects that could contribute to the contamination of drug products.”
Which sections are cited alongside 211.48?
In the same 483s, investigators most often also cite 211.67 (Equipment cleaning and maintenance), 211.160 (General requirements), 211.192 (Production record review), 211.22 (Responsibilities of quality control unit).