LifeSouth Community Blood Centers, Inc. – FDA Warning Letter, Nov 14, 2011

The FDA conducted an inspection of LifeSouth Community Blood Centers, Inc. in Huntsville, Alabama, from October 17 to November 14, 2011. The inspection revealed deviations from current Good Manufacturing Practice (cGMP) regulations for blood and blood products (21 CFR Parts 606 and 640), rendering their products adulterated.

Key violations include: 1. **Temperature Control:** Failure to store Red Blood Cells (RBC) between 1°C and 6°C, with coolers exceeding this range for extended periods without product relocation. (21 CFR 640.11(a)) 2. **Record Keeping:** Failure to maintain complete storage and distribution records, specifically discard records from September 2010 onwards, due to a lack of a computer source code to retrieve data from their (b)(4) system. Examples include unaccounted RBC components and missing final disposition documentation for discarded units. (21 CFR 606.160(b)(3)(i)) 3. **Distribution Records:** Failure to maintain distribution records that readily identify consignee, date, quantity, lot number, and expiration/collection date, as demonstrated by delayed documentation of a unit transfer. (21 CFR 606.165(b)) 4. **Supply and Reagent Storage:** Failure to monitor and control storage temperatures for quality control reagents and