FDA 483 - Miyoshi America, Inc - February 06, 2026

An FDA inspection of Miyoshi America, Inc., an API manufacturer in Danville, CT, revealed significant deficiencies in quality control. Observations included a failure to validate test methods and qualify reference standards, an inadequate supplier qualification program, and a quality unit that did not ensure CGMP compliance regarding waste management. Additionally, the firm's training program for laboratory personnel was found to be insufficient.