21 CFR 211.56
Sanitation
21 CFR 211.56 is the regulation titled “Sanitation” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 10 FDA warning letters have cited it.
- Letters citing it
- 10 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 211.113, in 5 letters
- Closed out
- 20% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (6 of 10). 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 211.56 most often, as written in the letters.
- 3 lettersYour firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition (21 CFR 211.56(a))
- 3 lettersYour firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects,…
- 1 letterFailure to establish and follow written procedures describing in sufficient detail the methods and materials used for sanitation [21 CFR 211.56(b)].** For example:
The regulation
Read the text of 21 CFR 211.56 (eCFR, as of Sep 1, 2026)
(a) Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals). Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner.
(b) There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; such written procedures shall be followed.
(c) There shall be written procedures for use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be followed. Rodenticides, insecticides, and fungicides shall not be used unless registered and used in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135).
(d) Sanitation procedures shall apply to work performed by contractors or temporary employees as well as work performed by full-time employees during the ordinary course of operations.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.56.
- 21 CFR 211.113Control of microbiological contamination5 letters cite both
- 21 CFR 211.166Stability testing5 letters cite both
- 21 CFR 211.100Written procedures; deviations4 letters cite both
- 21 CFR 211.192Production record review4 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures4 letters cite both
- 21 CFR 200.10Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers3 letters cite both
- 21 CFR 201.115New drugs or new animal drugs3 letters cite both
- 21 CFR 210.1Status of current good manufacturing practice regulations3 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.56 that FDA posted most recently.
- DrugsView ProRx, LLCsterile drug productsIssuedMar 4, 2025PostedMar 4, 2025
- DrugsView Fagron Compounding Services, LLC dba Fagron Sterile ServiceLidocaine HCl Injection, 2%IssuedDec 19, 2024PostedFeb 4, 2025
- DrugsView Choice All Natural, Inc. dba Om BotanicalOTC topical drug products including rash and itch creamIssuedOct 21, 2024PostedOct 29, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.