FDA 483 - A2A INTEGRATED LOGISTIC INC - February 18, 2025

During inspections conducted on February 18, 21, and 24, 2025, the FDA identified significant deficiencies at A2A INTEGRATED LOGISTIC INC, a wholesale drug distributor. The observations, detailed in an FDA 483 document, primarily highlight the company"s non-compliance with the Drug Supply Chain Security Act (DSCSA) and general good storage and distribution practices for pharmaceutical products. Key violations include the failure to establish adequate systems and processes for identifying, investigating, and reporting suspect or illegitimate drug products. The company"s Standard Operating Procedures were deemed insufficient, particularly in handling suspect products from various trading partners and notifying relevant parties. Furthermore, A2A INTEGRATED LOGISTIC INC repeatedly failed to maintain complete and accurate transaction information for drug products, both when receiving from upstream partners and providing to downstream partners, and could not provide documentation upon request. The inspection also revealed that the firm failed to respond properly to notifications of illegitimate product and did not maintain records of suspect product investigations. Critically, A2A INTEGRATED LOGISTIC INC engaged with unauthorized trading partners, thereby compromising supply chain integrity. The company also demonstrated a significant lapse in quality control, with observations noting the failure to calibrate essential equipment, monitor temperature in storage areas, conduct temperature mapping studies, and store drug products at their specified conditions. These issues necessitate comprehensive corrective actions to ensure compliance with federal regulations and safeguard drug product quality and security.