FDA 483 - Logistics Plus Fulfillment Solutions - January 13, 2020

Gacaca Inc. in Olean, NY, an initial importer, was inspected by the FDA on January 13, 2020. The inspection revealed a significant deficiency in the firm's corrective and preventive action (CAPA) procedures. The firm's CAPA policy lacked adequate details for investigating problems, preventing recurrence, implementing changes, disseminating information, and verifying the effectiveness of corrective actions.