Code of Federal Regulations Title 21. Food and Drugs § 21.1271.260 Storage

(a) Control of storage areas. You must control your storage areas and stock rooms to prevent:

(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:

(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.