21 CFR Part 1271 · Human Cells, Tissues, and Cellular and Tissue-Based Products

21 CFR 1271.215

Recovery

21 CFR 1271.215 is the regulation titled “Recovery” in 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Since 2021, 1 FDA warning letter has cited it.

Letters citing it
1 since 2021
Jan 1 to Oct 30, 2026
0 against 0 on the same dates in 2025
Most often cited with
21 CFR 1271.180, in 1 letter
Closed out
0% of these letters have a published close-out
See the letter citing 21 CFR 1271.215 →

Letters citing it, by year issued

It is a biologics letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.

  1. 12021
  2. 02022
  3. 02023
  4. 02024
  5. 02025
  6. 02026

The regulation

Read the text of 21 CFR 1271.215 (eCFR, as of Sep 1, 2026)

If you are an establishment that recovers HCT/Ps, you must recover each HCT/P in a way that does not cause contamination or cross-contamination during recovery, or otherwise increase the risk of the introduction, transmission, or spread of communicable disease through the use of the HCT/P.

Text from eCFR as of Sep 1, 2026.

Cited alongside it

Regulations that appear in the same letters as 21 CFR 1271.215.

Latest letters citing it

The letter citing 21 CFR 1271.215 that FDA posted most recently.

See the letter citing 21 CFR 1271.215 →
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