CFR section

21 CFR 211.48(a): Plumbing

PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart C-Buildings and Facilities

Key facts

Citation 21 CFR 211.48(a)
Section Plumbing
Part PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
Subpart Subpart C-Buildings and Facilities
Subchapter 21 CFR C Drugs General
Product types cited Devices, Drugs, Food/Cosmetics, General, Veterinary
Regulation text (excerpt) (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.

At a glance

  • 10–99 Inspections citing this section
  • 10–99 Warning letters citing this section

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About CFR sections cited by the FDA

Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.

Source: U.S. Code of Federal Regulations (eCFR); citation statistics from FDA inspection and warning-letter data

Browse all CFR sections cited by the FDA