FDA 483 - Miyoshi America, Inc - May 25, 2021

An FDA inspection of Miyoshi America, Inc., an API manufacturer in Dayville, Connecticut, revealed significant deficiencies across its quality, facilities, production, and laboratory systems. Key issues included inadequate investigations into product failures, untimely corrective actions, insufficient cleaning procedures, and a deficient preventative maintenance program. The firm also failed to adequately validate rework processes and maintain complete and secure laboratory control records, raising concerns about data integrity and product quality.