21 CFR 1271.195
Environmental control and monitoring
21 CFR 1271.195 is the regulation titled “Environmental control and monitoring” in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 1271.220, in 2 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are biologics 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 1271.195 most often, as written in the letters.
- 1 letterFailure to monitor environmental conditions where they could reasonably be expected to cause contamination or cross contamination of HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable disease agents…
The regulation
Read the text of 21 CFR 1271.195 (eCFR, as of Sep 1, 2026)
(a) Environmental control. Where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable disease agents, you must adequately control environmental conditions and provide proper conditions for operations. Where appropriate, you must provide for the following control activities or systems:
(1) Temperature and humidity controls;
(2) Ventilation and air filtration;
(3) Cleaning and disinfecting of rooms and equipment to ensure aseptic processing operations; and
(4) Maintenance of equipment used to control conditions necessary for aseptic processing operations.
(b) Inspections. You must inspect each environmental control system periodically to verify that the system, including necessary equipment, is adequate and functioning properly. You must take appropriate corrective action as necessary.
(c) Environmental monitoring. You must monitor environmental conditions where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT/Ps or equipment, or accidental exposure of HCT/Ps to communicable disease agents. Where appropriate, you must provide environmental monitoring for microorganisms.
(d) Records. You must document, and maintain records of, environmental control and monitoring activities.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.195.
- 21 CFR 1271.220Processing and process controls2 letters cite both
- 21 CFR 1271.230Process validation2 letters cite both
- 21 CFR 1271.160Establishment and maintenance of a quality program1 letter cites both
- 21 CFR 1271.180Procedures1 letter cites both
- 21 CFR 1271.190Facilities1 letter cites both
- 21 CFR 1271.200Equipment1 letter cites both
- 21 CFR 1271.210Supplies and reagents1 letter cites both
- 21 CFR 1271.215Recovery1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 1271.195 that FDA posted most recently.
- BiologicsView OsteoLife Biomedical I LLCFreeze-Dried Particulate Bone, Flexo-Plate, Flexo-MembraneIssuedMar 31, 2022PostedMay 31, 2022
- BiologicsView Utah Cord Bank LLChuman cells, tissues, and cellular and tissue-based products (HCT/Ps) recovered from donors between May 25, 2005 and February 11, 2021IssuedMay 11, 2021PostedJun 1, 2021
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Counts include every citation in a letter, as the Letters filter does. How this database is built.