21 CFR 211.46
Ventilation, air filtration, air heating and cooling
21 CFR 211.46 is the regulation titled “Ventilation, air filtration, air heating and cooling” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 200.10, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 12024
- 02025
- 02026
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.46 most often, as written in the letters.
- 1 letterYour firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b))
- 1 letterYour firm failed to provide equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature when appropriate for the manufacture, processing, packing, or holding of a drug product (21…
The regulation
Read the text of 21 CFR 211.46 (eCFR, as of Sep 1, 2026)
(a) Adequate ventilation shall be provided.
(b) Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature shall be provided when appropriate for the manufacture, processing, packing, or holding of a drug product.
(c) Air filtration systems, including prefilters and particulate matter air filters, shall be used when appropriate on air supplies to production areas. If air is recirculated to production areas, measures shall be taken to control recirculation of dust from production. In areas where air contamination occurs during production, there shall be adequate exhaust systems or other systems adequate to control contaminants.
(d) Air-handling systems for the manufacture, processing, and packing of penicillin shall be completely separate from those for other drug products for human use.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.46.
- 21 CFR 200.10Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers1 letter cites both
- 21 CFR 201.115New drugs or new animal drugs1 letter cites both
- 21 CFR 210.1Status of current good manufacturing practice regulations1 letter cites both
- 21 CFR 211.113Control of microbiological contamination1 letter cites both
- 21 CFR 211.192Production record review1 letter cites both
- 21 CFR 211.67Equipment cleaning and maintenance1 letter cites both
- 21 CFR 211.94Drug product containers and closures1 letter cites both
Latest letters citing it
The letter citing 21 CFR 211.46 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.