FDA 483 - Biomat USA Inc

GCAM, Inc. in Indianapolis, IN, a source plasma establishment, was cited for significant deficiencies in its quality system and operational procedures during an FDA inspection. Observations included inadequate standard operating procedures for blood component processing and donor eligibility, exculpatory language in the informed consent, and failures in quality unit record review and adherence to donor reaction protocols. These issues indicate a lack of robust controls over critical aspects of plasma collection and donor safety.