21 CFR 211.67: Equipment cleaning and maintenance
Manufacturers must clean, maintain, and sanitize or sterilize equipment at appropriate intervals under written procedures covering responsibilities, schedules, methods, batch ID removal, contamination protection, and pre-use inspection, and must keep records of these activities.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart D, Equipment
33%
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 211.67, from the 483s we hold.
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.Most used
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.211.67(b)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.211.67(a)
Cited over time
483s citing 211.67, 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 211.67
- Victory Medical Center Pharmacy · Austin, TexasSep 10, 2026
- Greenwich Rx · Tomball, TexasCompounding with components, containers or other materials that have not been… Sep 9, 2026
- Houston Rx LLC · Houston, TexasUse of cleaning and disinfecting agents that may leave residues or not adequately… Aug 28, 2026
- Carolina Infusion, LLC · Ridgeland, South CarolinaHazardous drugs and Highly potent drugs were produced without providing adequate… Aug 18, 2026
- CD Pharmacy, LLC dba Red Rock Pharmacy · Springville, UtahHazardous drugs were produced without providing adequate containment, segregation,… Jul 31, 2026
The regulation text
§ 211.67 Equipment cleaning and maintenance.
(a)Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
(b)Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not necessarily limited to, the following:
(1)Assignment of responsibility for cleaning and maintaining equipment;
(2)Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules;
(3)A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance;
(4)Removal or obliteration of previous batch identification;
(5)Protection of clean equipment from contamination prior to use;
(6)Inspection of equipment for cleanliness immediately before use.
(c)Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified in §§ 211.180 and 211.182.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51931, Sept. 8, 2008]
Questions
What does 21 CFR 211.67 require?
Manufacturers must clean, maintain, and sanitize or sterilize equipment at appropriate intervals under written procedures covering responsibilities, schedules, methods, batch ID removal, contamination protection, and pre-use inspection, and must keep records of these activities.
How often is 211.67 cited in Form 483s?
It appears in about 33% of the drug-manufacturing 483s we hold from 2023 onward, which makes it one of the five most-cited sections in those 483s.
How do FDA investigators word a 211.67 observation?
The most common opening is: “Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.”
Which sections are cited alongside 211.67?
In the same 483s, investigators most often also cite 211.192 (Production record review), 211.22 (Responsibilities of quality control unit), 211.160 (General requirements), 211.113 (Control of microbiological contamination).