21 CFR 211.63
Equipment design, size, and location. This section left the CFR when the QMSR took effect on Feb 2, 2026; the text below is as of Feb 1, 2026.
- Inspections citing it: 698
- Of those classified, ended OAI: 36%
- Last cited: FY2026
Inspections Citing It by Fiscal Year
Sites in and outside the US, FY2017 to Oct 20, 2026.
Regulation Text
eCFR, as of Feb 1, 2026Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.
Recently Cited Sites
Newest inspections citing this section; each opens the site- Episciences IncUnited States · Jul 31, 2026
- Biochemical and Scientific Consultants ccSouth Africa · Jul 20, 2026
- Advanced Cosmetic Research Laboratories, Inc.United States · Jun 26, 2026
- My CHS Rx, Inc.United States · Jun 5, 2026
Counts are inspections with posted citations that cite any paragraph of the section, once per inspection, from FDA's Data Dashboard. OAI share is over inspections FDA finally classified. Text from eCFR, the official online CFR. FDA Data Dashboard and eCFR