21 CFR 1271.250
Labeling controls
21 CFR 1271.250 is the regulation titled “Labeling controls” 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
Letters citing it, by year issued
It is a biologics letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 12021
- 02022
- 02023
- 02024
- 02025
- 02026
The regulation
Read the text of 21 CFR 1271.250 (eCFR, as of Sep 1, 2026)
(a) General. You must establish and maintain procedures to control the labeling of HCT/Ps. You must design these procedures to ensure proper HCT/P identification and to prevent mix-ups.
(b) Verification. Procedures must include verification of label accuracy, legibility, and integrity.
(c) Labeling requirements. Procedures must ensure that each HCT/P is labeled in accordance with all applicable labeling requirements, including those in §§ 1271.55, 1271.60, 1271.65, 1271.90, 1271.290, and 1271.370, and that each HCT/P made available for distribution is accompanied by documentation of the donor eligibility determination as required under § 1271.55.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.250.
- 21 CFR 1271.180Procedures1 letter cites both
- 21 CFR 1271.190Facilities1 letter cites both
- 21 CFR 1271.195Environmental control and monitoring1 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
- 21 CFR 1271.220Processing and process controls1 letter cites both
- 21 CFR 1271.230Process validation1 letter cites both
Latest letters citing it
The letter citing 21 CFR 1271.250 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.