FDA EIR - Hemacare Corp - June 27, 2003

An FDA inspection of HemaCare Corporation/Coral Blood Services, Inc. (CBS), operating at Mount Auburn Hospital in Cambridge, MA, took place from June 25-27, 2003. This follow-up inspection was initiated due to prior issues at other Coral facilities, focusing on CBS's donor operations including registration, histories, blood collection, and component separation. The inspection resulted in an FDA Form 483 with one key finding: CBS failed to maintain comprehensive reports of adverse reactions related to blood collection. Specifically, a form for a moderate donor reaction involving anticubital discomfort was not forwarded to the Coral Medical Director, a direct violation of CBS's standard operating procedures (SOP COR-OPS-CLIN-057) and 21 CFR 606.170(a). This indicated a breakdown in their reaction management process. During the closing discussion, Coral Blood Services management, through its Chief Operating Officer, pledged to rectify this observation within 30 days. This inspection underscored the critical need for strict compliance with internal procedures and regulatory mandates concerning donor safety information management.