21 CFR 1271.220
Processing and process controls
21 CFR 1271.220 is the regulation titled “Processing and process controls” 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 1271.195, 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 1271.220 most often, as written in the letters.
- 1 letterFailure to process HCT/Ps in a way that does not cause contamination or cross-contamination during processing and that prevents the introduction, transmission, or spread of communicable disease through the use of the…
The regulation
Read the text of 21 CFR 1271.220 (eCFR, as of Sep 1, 2026)
(a) General. If you are an establishment that processes HCT/Ps, you must process each HCT/P in a way that does not cause contamination or cross-contamination during processing, and that prevents the introduction, transmission, or spread of communicable disease through the use of the HCT/P.
(b) Pooling. Human cells or tissue from two or more donors must not be pooled (placed in physical contact or mixed in a single receptacle) during manufacturing.
(c) In-process control and testing. You must ensure that specified requirements, consistent with paragraph (a) of this section, for in-process controls are met, and that each in-process HCT/P is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received and documented. Sampling of in-process HCT/Ps must be representative of the material to be evaluated.
(d) Dura mater. (1) When there is a published validated process that reduces the risk of transmissible spongiform encephalopathy, you must use this process for dura mater (or an equivalent process that you have validated), unless following this process adversely affects the clinical utility of the dura mater.
(2) When you use a published validated process, you must verify such a process in your establishment.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.220.
- 21 CFR 1271.195Environmental control and monitoring2 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 1271.220 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.