FDA WARNING_LETTER - LifeServe Blood Center - June 27, 2013

The FDA conducted an inspection at LifeServe Blood Center from June 13-27, 2013, identifying significant deviations from cGMP for blood and blood components (21 CFR Part 606 and 610), rendering products adulterated under 21 USC 351(a)(2)(B).

Violations include: 1. **Failure to test blood and blood components according to manufacturer's instructions (21 CFR 610.40(b))**: On January 17, 2012, mini-pool samples for units (b)(7)(c); (b)(6), (b)(7)(c); (b)(6), and (b)(7)(c); (b)(6) tested reactive via NAT. Subsequent individual resolution samples also tested reactive. Discriminatory testing results were "unresolved." Despite this, non-reactive retest results from different samples were used as the test of record, inappropriately invalidating initial reactive results. The firm misinterpreted FDA guidance and failed to acknowledge this deviation in their July 11, 2013, response. 2. **Failure to defer donors with reactive screening tests and restrict use of their blood (21 CFR 610.41(a), 610.40(h)(1))**: Donors (b)(7)(c); (b)(6), (