Current through September 30, 2024
Section 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:(2) Processing, including the method of preservation;(3) Storage conditions; and(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.