C & A Scientific Company, Inc. – FDA 483, Oct 16, 2024

An FDA inspection of C & A Scientific Company, Inc., an initial importer/repacker in Sterling, VA, revealed a pervasive lack of established, documented, and implemented procedures across numerous critical quality system areas. The firm failed to define essential processes for complaints, nonconformance, incoming product acceptance, CAPA, purchasing, personnel training, quality audits, and management review. These widespread deficiencies indicate a fundamental absence of a functional quality system.