21 CFR 211.182
Equipment cleaning and use log
21 CFR 211.182 is the regulation titled “Equipment cleaning and use log” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 4 FDA warning letters have cited it.
- Letters citing it
- 4 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 4 letters
- Closed out
- 25% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 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 211.182 most often, as written in the letters.
- 1 letterYour firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, you failed to ensure:
The regulation
Read the text of 21 CFR 211.182 (eCFR, as of Sep 1, 2026)
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]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.182.
- 21 CFR 211.22Responsibilities of quality control unit4 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures4 letters cite both
- 21 CFR 211.100Written procedures; deviations3 letters cite both
- 21 CFR 211.180General requirements3 letters cite both
- 21 CFR 211.188Batch production and control records3 letters cite both
- 21 CFR 201.128Meaning of “intended uses”2 letters cite both
- 21 CFR 211.160General requirements2 letters cite both
- 21 CFR 211.166Stability testing2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.182 that FDA posted most recently.
- DrugsView Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim SirketiOTC drug productsIssuedMar 12, 2025PostedMar 18, 2025
- DrugsView Eurosirel S.P.Atopical drug products including (b)(4) and pain patchesIssuedNov 20, 2024PostedNov 26, 2024
- DrugsView Aerosol and Liquid Packaging, Inc.OTC drug products including skin and wound cleanser antiseptic sprayIssuedJul 24, 2024PostedSep 24, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.