21 CFR 1271.260 - Storage.
(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.
Title 21 published on 2013-04-01
no entries appear in the Federal Register after this date.