FDA 483 - Huron Tool & Cutter Grinding Co - December 05, 2023

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.