21 CFR 1271.260: Storage
Requires HCT/P establishments to control storage areas to prevent mix-ups, contamination and improper release, store at appropriate recorded temperatures within set limits, assign expiration dates where appropriate, and document corrective action when storage conditions fail.
Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products · Subpart D, Current Good Tissue Practice
Recent 483s citing 1271.260
- Cornerstone Medical Associates, Inc · Fresno, CaliforniaStorage temperatures of HCT/Ps were not recorded and maintained… Sep 3, 2025
- Liveyon · Yorba Linda, CaliforniaStorage temperatures ofHCT/Ps were not recorded and maintained… Sep 21, 2018
- DePuy Sa n Antonio · San Antonio, TexasStorage temperatures ofHCT/Ps were not recorded… Oct 28, 2009
- Musculoskeletal Transplant Foundation · Edison, New JerseyStorage areas and stock rooms were not controlled to prevent mix-ups, contamination… Mar 13, 2009
The regulation text
§ 1271.260 Storage.
(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.
Questions
What does 21 CFR 1271.260 require?
Requires HCT/P establishments to control storage areas to prevent mix-ups, contamination and improper release, store at appropriate recorded temperatures within set limits, assign expiration dates where appropriate, and document corrective action when storage conditions fail.
Which sections are cited alongside 1271.260?
In the same 483s, investigators most often also cite 1271.265 (Receipt, predistribution shipment, and distribution of an HCT/P), 1271.150 (Current good tissue practice requirements), 1271.160 (Establishment and maintenance of a quality program), 1271.180 (Procedures).