21 CFR 211.46
Equipment for Environmental Control
- Inspections citing it: 222
- Of those classified, ended OAI: 32%
- Last cited: FY2026
Inspections Citing It by Fiscal Year
Sites in and outside the US, FY2017 to Oct 20, 2026.
Paragraphs Cited
As FDA posts them, all years.
- 211.46(b)
- 165 · Equipment for Environmental Control
- 211.46(c)
- 44 · Exhaust systems inadequate to control air contamination
- 211.46(d)
- 7 · Penicillin air handling systems not kept separate
- 211.46(a)
- 6 · Adequate ventilation not provided
Regulation Text
eCFR did not answer; open it on eCFRRecently Cited Sites
Newest inspections citing this section; each opens the site- Shine Spect USA, LLCUnited States · Jul 10, 2026
- Perrigo New York, Inc.United States · May 8, 2026
- Element Materials Technology Boston - Acton Inc.United States · May 4, 2026
- Gallant Pet IncUnited States · Feb 27, 2026
- Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S.Türkiye · Feb 27, 2026
- Signature Formulations, LLCUnited States · Jul 29, 2025
- Dextrum LaboratoriesUnited States · Jul 18, 2023
- TERUMO CORPORATIONJapan · Mar 21, 2023
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