§ 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.

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 § 211.48

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

• Plumbing System Defects 38
• Drains--Size, Back-siphonage Prevention 10
• Potable water standards not met 8
• Potable water not under positive pressure 2

Amendment history

Federal Register documents that created or amended this section.

• 43 FR 45077 29 Sept 1978
• 48 FR 11426 18 Mar 1983