21 CFR 1271.230
Process validation
21 CFR 1271.230 is the regulation titled “Process validation” in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 3 FDA warning letters have cited it.
- Letters citing it
- 3 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 1271.230 most often, as written in the letters.
- 1 letterFailure to validate and approve a process according to established procedures where the results of processing cannot be fully verified by subsequent inspections and tests. The validation activities and results must be…
- 1 letterFailure to validate and approve processes according to established procedures where the results of processing cannot be fully verified by subsequent inspections and tests [21 CFR 1271.230(a)]. For example:
- 1 letteryou failed to validate the manufacturing process for your dehydrated, dual layer amniotic membrane patch, TheraMend, which cannot be fully verified, to ensure that your process does not cause contamination or…
The regulation
Read the text of 21 CFR 1271.230 (eCFR, as of Sep 1, 2026)
(a) General. Where the results of processing described in § 1271.220 cannot be fully verified by subsequent inspection and tests, you must validate and approve the process according to established procedures. The validation activities and results must be documented, including the date and signature of the individual(s) approving the validation.
(b) Written representation. Any written representation that your processing methods reduce the risk of transmission of communicable disease by an HCT/P, including but not limited to, a representation of sterility or pathogen inactivation of an HCT/P, must be based on a fully verified or validated process.
(c) Changes. When changes to a validated process subject to paragraph (a) of this section occur, you must review and evaluate the process and perform revalidation where appropriate. You must document these activities.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.230.
- 21 CFR 1271.195Environmental control and monitoring2 letters cite both
- 21 CFR 1271.220Processing and process controls2 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 3 letters citing 21 CFR 1271.230 that FDA posted most recently.
- BiologicsView Lux Therapeutics LLC dba Ponya Therapeutics LLCTheraMend dehydrated dual layer amniotic membrane patchIssuedNov 25, 2025PostedDec 9, 2025
- 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.