21 CFR 211.46: Ventilation, air filtration, air heating and cooling
Requires drug manufacturers to provide adequate ventilation, appropriate controls for air pressure, microbes, dust, humidity and temperature, suitable air filtration and exhaust, and fully separate air-handling systems for penicillin versus other human drugs.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart C, Buildings and Facilities
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 211.46, from the 483s we hold.
Equipment for adequate control over humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.Most used
Equipment for adequate control over air pressure is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.211.46(b)
Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.211.46(b)
Cited over time
483s citing 211.46, 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 211.46
- Perrigo New York, Inc. · Bronx, New YorkEquipment for adequate control over air pressure is not provided when appropriate… May 8, 2026
- Tarmac Products, Inc. · Miami Gardens, FloridaEquipment for adequate control over humidity and temperature is not provided when… Feb 6, 2026
- FDA Form 483 Lonza Portsmouth, NH June 2025 · —Heating, ventilation, and air conditioning maintenance and controls are inadequate… Jun 6, 2025
- Acino Products, LLC · Hamilton, New JerseyEquipment for adequate control over humidity and temperature is not provided when… May 21, 2025
- Mankind Pharma Limited · Kotputli-Behror, Rajasthan, IndiaBuildings used in the manufacturing of Intermediates and finished APIs are not… Apr 26, 2025
The regulation text
§ 211.46 Ventilation, air filtration, air heating and cooling.
(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.
Questions
What does 21 CFR 211.46 require?
Requires drug manufacturers to provide adequate ventilation, appropriate controls for air pressure, microbes, dust, humidity and temperature, suitable air filtration and exhaust, and fully separate air-handling systems for penicillin versus other human drugs.
How often is 211.46 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 211.46 observation?
The most common opening is: “Equipment for adequate control over humidity and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.”
Which sections are cited alongside 211.46?
In the same 483s, investigators most often also cite 211.113 (Control of microbiological contamination), 211.42 (Design and construction features), 211.67 (Equipment cleaning and maintenance), 211.160 (General requirements).