21 CFR 211.63: Equipment design, size, and location
Requires that equipment used to make, process, pack, or hold drug products be appropriately designed, adequately sized, and suitably located to support its intended use, cleaning, and maintenance.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart D, Equipment
11%
of drug-manufacturing 483s since 2023 cite this section at least once
How FDA words it
The opening lines investigators use most when they cite 211.63, from the 483s we hold.
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.Most used
Equipment used in the manufacture, processing, packing or holding of ding products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Equipment used in the manufacture, processing, packing or holding of drug products is not suitably located to facilitate operations for its intended use.
Cited over time
483s citing 211.63, by yearMost citations in 2023. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2023.
Recent 483s citing 211.63
- Victory Medical Center Pharmacy · Austin, TexasProduction areas have difficult to clean or contain porous, particle generating, or… Sep 10, 2026
- Tai ls t o rm Hea l th · Chandler, ArizonaEquipment used in the manufacture, processing, packing or holding of drug products… Aug 28, 2026
- Imprimis NJOF, LLC · Ledgewoo d, New JerseyEquipment used in the manufacture, processing, packing or holding of drug products… Aug 18, 2026
- Emcure Pharmaceuticals Limited · Ahmedabad, Gujarat, IndiaEquipment used in the manufacture, processing, packing or holding of drug products… May 15, 2026
- PQ Pharmacy LLC · Brooksville, FloridaEquipment used in the manufacture, processing, packing or holding of drug products… Apr 20, 2026
The regulation text
§ 211.63 Equipment design, size, and location.
Equipment 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.
Questions
What does 21 CFR 211.63 require?
Requires that equipment used to make, process, pack, or hold drug products be appropriately designed, adequately sized, and suitably located to support its intended use, cleaning, and maintenance.
How often is 211.63 cited in Form 483s?
It appears in about 11% of the drug-manufacturing 483s we hold from 2023 onward.
How do FDA investigators word a 211.63 observation?
The most common opening is: “Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.”
Which sections are cited alongside 211.63?
In the same 483s, investigators most often also cite 211.192 (Production record review), 211.67 (Equipment cleaning and maintenance), 211.22 (Responsibilities of quality control unit), 211.160 (General requirements).