21 CFR 211.182
Equipment cleaning and use log.
- Inspections citing it: 313
- Of those classified, ended OAI: 24%
- 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 Nov 6, 2026A 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.
Recently Cited Sites
Newest inspections citing this section; each opens the site- Conopco Inc. d/b/a UnileverUnited States · Jul 13, 2026
- Nexus Pharmaceuticals, LLCUnited States · Jun 4, 2026
- Aspire Pharmaceuticals, Inc.United States · Apr 24, 2026
- Eosera, Inc.United States · Mar 20, 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