FDA 483 - Criterion Tool & Die Inc - February 17, 2023

Criterion Tool & Die Inc, a contract medical device manufacturer in Brookpark, OH, received a Form FDA 483 following an inspection from February 8-17, 2023. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for corrective and preventive actions, complaint handling, nonconforming product control, supplier approval, process validation, equipment maintenance, and employee training. These issues indicate a systemic lack of established and implemented quality management processes.