483
Miyoshi America, IncMiyoshi America, Inc – FDA 483, Feb 6, 2026
Record Details
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
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