21 CFR 211.182: Equipment cleaning and use log
Requires manufacturers to keep chronological, signed or initialed equipment logs recording cleaning, non-routine maintenance, and use (date, time, product, lot), or batch-record entries when equipment is dedicated to one product.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart J, Records and Reports
2%
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 211.182, from the 483s we hold.
Written records of major equipment cleaning, maintenance and use are not included in individual equipment logs.Most used
Written records of major equipment use are not included in individual equipment logs.
Individual equipment logs do not show time, date, product and lot number of each batch processed.
Cited over time
483s citing 211.182, 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 211.182
- Eosera, Inc · Fort Worth, TexasIndividual equipment logs do not show time, date, product and lot number of each… Mar 20, 2026
- Accra-Pac, Inc. · Elkhart, IndianaRecords are not kept for the cleaning of equipment… Mar 5, 2026
- DOH Central Pharmacy · Tallahassee, FloridaWritten records of major equipment cleaning and use are not included in individual… Jul 28, 2025
- Creative Essences Inc · Santa Fe Springs, CaliforniaWritten records of major equipment cleaning, maintenance and use are not included… Mar 25, 2025
- AIDANCE SCIENTIFIC INC DBA AIDANCE SKINCARE & TOPICAL SOLUTIONS · Woonsocket, Rhode IslandWritten records of major equipment cleaning, maintenance and use are not included… Feb 12, 2025
The regulation text
§ 211.182 Equipment cleaning and use log.
A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. The persons performing and double-checking the cleaning and maintenance (or, if the cleaning and maintenance is performed using automated equipment under § 211.68, just the person verifying the cleaning and maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order.
[73 FR 51933, Sept. 8, 2008]
Questions
What does 21 CFR 211.182 require?
Requires manufacturers to keep chronological, signed or initialed equipment logs recording cleaning, non-routine maintenance, and use (date, time, product, lot), or batch-record entries when equipment is dedicated to one product.
How often is 211.182 cited in Form 483s?
It appears in about 2% of the drug-manufacturing 483s we hold from 2023 onward.
How do FDA investigators word a 211.182 observation?
The most common opening is: “Written records of major equipment cleaning, maintenance and use are not included in individual equipment logs.”
Which sections are cited alongside 211.182?
In the same 483s, investigators most often also cite 211.22 (Responsibilities of quality control unit), 211.160 (General requirements), 211.192 (Production record review), 211.67 (Equipment cleaning and maintenance).