FDA WARNING_LETTER - Community Blood Centers Of Florida, Inc. - December 19, 2011

The FDA inspected Community Blood Centers of Florida, Inc. from September 1, 2011, to December 19, 2011, identifying deviations from current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals (21 CFR Part 211) and blood/blood components (21 CFR Parts 600, 610, 640), rendering products adulterated.

Key violations include: 1. **Failure to maintain donor records (21 CFR 606.160(b)(1)(vii))**: At least thirteen ABO discrepancies from a 2007 inspection persisted, with donor registration information entered over existing records, leading to units being associated with incorrect "John Doe" records. 2. **Failure to notify consignees of HIV test results within 45 days (21 CFR 610.46(a)(1)(ii)(B), (3))**: One instance showed an 87-day delay in notifying a consignee of a donor's confirmed HIV-positive status. 3. **Failure to review records before product release (21 CFR 606.100(c))**: A pooled platelet unit was distributed and transfused despite a single donor unit, retrieved from biohazardous waste, being added after 21 hours without temperature control or agitation. 4. **Improper use of