Recipient:Community Blood Centers of Florida, Inc. .
Product:blood and blood components
The Food and Drug Administration (FDA) conducted an inspection of your firm, Community Blood Centers of Florida, Inc., from September 1, 2011 – December 19, 2011. During the inspection, FDA investigators documented deviations from applicable current Good Manufacturing Practice for Finished Pharmaceuticals (21 CFR Part 211) and current Good Manufacturing Practice (cGMP) regulations for blood and blood components, Title 21 Code of Federal Regulations (21 CFR) Parts 600, 610 and 640. These deviations cause your blood products to be adulterated within the meaning of Section 501 (a)(2)(B) of the Federal Food, Drug and Cosmetic Act (the Act), [21 U.S.C. 351 (a)(2)(B)]. These deviations include but are not limited to the following:
1) Failure to maintain records that include, but are not limited to, records to relate the donor with the unit number of each previous donation from that donor [21 CFR 606.160(b)(1)(vii)]. At least thirteen ABO discrepancies were noted during the previous inspection in July, 2007 and the discrepant units were still found to be associated with the wrong donor records during the current inspection.
a) Registration information for a donor was entered over the existing record of another donor. The discrepant record was registered under “John Doe” and your firm failed to update the donor records to relate the unit number to the actual donor.
b) Registration information for a donor was entered over the existing record of another donor. Your firm failed to identify the donor of the unit and it was discovered during the inspection that the discrepant unit was still associated with the wrong donor record.
Failure to use supplies and reagents in a manner consistent with the instruction provided by the manufacturer [21 CFR 606.65 (e)].
c) Your firm’s quality control unit failed to conduct a complete investigation of issues related to the interface between your Regulated Software Collections Application (RSA) and BioMerieux Clinical Diagnostics BAC-T Alert computer systems. You therefore failed to ensure the satisfactory transfer of bacterial testing results of platelet products.
6) Failure to maintain records concurrently with the performance of each significant step in the collection, processing, compatibility testing, storage and distribution of each unit of blood and blood components so that all steps can be clearly traced [21 CFR 606.160 (a)(1)]. Failure of your distribution records to contain information to readily facilitate the identification of the name and address of the consignee, the date and quantity delivered, the lot number of the unit(s) the date of expiration or the date of collection, whichever is applicable, or for crossmatched blood and blood components, the name of the recipient [21 CFR 606.165(b)].
FDA District: Florida District