483
Micro Stamping CorpFDA 483 - Micro Stamping Corp - February 25, 2020
Record Details
An FDA inspection of Mico Stamping Corp in Somerset, NJ, a contract manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish corrective and preventive action procedures and did not properly investigate customer complaints. Additionally, a critical manufacturing process was not adequately validated, leading to high rework rates for commercially distributed products.
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ID · 4c48e0e2-48e6-42d5-8667-3cf79028c907