Blood Center of New Jersey – FDA Warning Letter, Dec 27, 2007

An FDA inspection of The Blood Center of New Jersey, conducted from August 17 to December 27, 2007, revealed numerous deviations from 21 CFR Parts 600-680, rendering their blood products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act. Key violations included the failure to maintain and follow standard operating procedures for determining donor suitability (21 CFR 606.100(b)), failure to determine donor suitability on the day of collection (21 CFR 640.3(a)(1)), and inadequate investigations for discrepancies (21 CFR 606.100(c)). The firm also failed to follow written SOPs for blood component collection, processing, and distribution (21 CFR 606.100(b)), and personnel were deemed inadequate in numbers or training (21 CFR 606.20). A significant repeat violation was the failure to submit timely Biological Product Deviation Reports (BPDRs) within 45 days (21 CFR 606.171), a deficiency noted in three prior inspections. The FDA reviewed the firm's January 14, 2008, response to the FDA-483 but found it insufficient, particularly regarding an SOP for a specific observation. The firm must take prompt corrective actions and notify the FDA within 15 working days, or face potential administrative and regulatory actions, including seizure or injunction.