Product: blood bank
During an inspection of your unlicensed blood bank, conducted on July 26, 30 and August 1, 2001, our investigator documented violations of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act and Title 21, Code of Federal Regulations 211 and 600-680, as follows:
Failure to conduct validation studies on the [redacted] software used to control irradiation dose calculation, irradiation timing, product expiration dating and electronic data reporting [21 CFR 211.100(b)].
Failure to establish written procedures that include all steps to be followed in the collection, processing, compatibility testing, storage and distribution of blood [21 CFR 606.100(b)]. For example, no written procedures exist that define the [redacted] software are Donor Module that has been in. use at your facility since November 1998.
Issuing Office: Chicago District