FDA 483 - Unknown Company - October 29, 2010

This FDA Form 483 documents significant deficiencies at the American Red Cross (ARC) Donor Client Support Center (DCSC) in Philadelphia, Pennsylvania, following the consolidation of donor management activities from 35 regional offices between May 2008 and March 2010.

The primary violation cited is ARC's failure to comply with Paragraph IV of the Amended Consent Decree of Permanent Injunction (April 15, 2003), specifically regarding the establishment, implementation, and continuous maintenance of adequate methods, facilities, systems, and controls to prevent the collection, manufacturing, processing, packing, holding, or distribution of adulterated or misbranded drug articles, as required by the FD&C Act, PHS Act, and 21 CFR Parts 210-211 and 600-680.

Key findings indicate chronic understaffing and a lack of process controls within the DCSC, leading to untimely and inadequate performance of critical donor management functions. Management was aware of these issues, including an approximate 18,000-case backlog of unverified donor management cases in April 2010 (11,531 in Charlotte and 3,552 in Philadelphia at the time of inspection), but allowed consolidation to continue.

Specific quality system and manufacturing issues include: * **Quality Assurance (QA) Deficiencies:** Failure to ensure effective donor management operations. Back