483
Miyoshi America, IncFDA 483 - Miyoshi America, Inc - February 06, 2026
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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.
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ID · 03e73d7b-d872-4aff-b0b1-c9d1892c555d