21 CFR 1271.260
Storage
21 CFR 1271.260 is the regulation titled “Storage” 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 1271.260 (eCFR, as of Sep 1, 2026)
(a) Control of storage areas. You must control your storage areas and stock rooms to prevent:
(1) Mix-ups, contamination, and cross-contamination of HCT/Ps, supplies, and reagents, and
(2) An HCT/P from being improperly made available for distribution.
(b) Temperature. You must store HCT/Ps at an appropriate temperature.
(c) Expiration date. Where appropriate, you must assign an expiration date to each HCT/P based on the following factors:
(1) HCT/P type;
(2) Processing, including the method of preservation;
(3) Storage conditions; and
(4) Packaging.
(d) Corrective action. You must take and document corrective action whenever proper storage conditions are not met.
(e) Acceptable temperature limits. You must establish acceptable temperature limits for storage of HCT/Ps at each step of the manufacturing process to inhibit the growth of infectious agents. You must maintain and record storage temperatures for HCT/Ps. You must periodically review recorded temperatures to ensure that temperatures have been within acceptable limits.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 1271.260.
- 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 1271.260 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.