21 CFR 211.67
Equipment cleaning and maintenance
21 CFR 211.67 is the regulation titled “Equipment cleaning and maintenance” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 106 FDA warning letters have cited it.
- Letters citing it
- 106 since 2021
- Jan 1 to Oct 30, 2026
- 17 against 17 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 60 letters
- Closed out
- 10% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (101 of 106). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.67 most often, as written in the letters.
- 32 lettersYour firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b))
- 26 lettersYour firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter…
- 2 lettersYour firm failed to clean, maintain, and sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or…
The regulation
Read the text of 21 CFR 211.67 (eCFR, as of Sep 1, 2026)
(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]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.67.
- 21 CFR 211.22Responsibilities of quality control unit60 letters cite both
- 21 CFR 211.100Written procedures; deviations58 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures54 letters cite both
- 21 CFR 211.192Production record review46 letters cite both
- 21 CFR 211.165Testing and release for distribution41 letters cite both
- 21 CFR 211.166Stability testing29 letters cite both
- 21 CFR 211.42Design and construction features23 letters cite both
- 21 CFR 211.160General requirements21 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.67 that FDA posted most recently.
- DrugsView Rohto Pharmaceutical Co., Ltd.Over-the-counter topical ophthalmic drug products manufactured using aseptic processing.IssuedOct 14, 2026PostedOct 20, 2026
- DrugsView SnugZ USA, Inc.OTC drug products distributed as promotional itemsIssuedSep 28, 2026PostedOct 20, 2026
- DrugsView Stream2Sea, LLCOTC drug productsIssuedFeb 2, 2026PostedSep 29, 2026
Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.