483
Huron Tool & Cutter Grinding CoHuron Tool & Cutter Grinding Co – FDA 483, Dec 5, 2023
Record Details
An FDA inspection of Huron Tool & Cutter Grinding Co in Farmingdale, NY, revealed significant deficiencies in the documentation of corrective and preventive action (CAPA) activities. The firm failed to adequately document several CAPA reports, specifically lacking justifications for completion timelines and verification sections. This indicates a moderate level of non-compliance with quality system documentation requirements.
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ID · 351e8efa-84a5-4656-818f-7bd0b251e900
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