FDA 483 - Ducommun Labarge Technologies - June 27, 2025
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An FDA inspection of Ducommun Labarge Technologies in Appleton, WI, revealed significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately establish procedures for corrective and preventive actions, lacked proper validation for a critical manufacturing process, and did not ensure adequate acceptance activities for incoming materials. These issues indicate a need for improved quality control and adherence to regulatory requirements.
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