FDA 483 - DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Hennrietta - October 12, 2023

This 483 report for DJ Acquisition FTT LLC, DBA Weco Manufacturing Group - Henrietta, a medical device manufacturer in Rochester, NY, details significant deficiencies in their quality system. The inspection revealed inadequate procedures for controlling nonconforming products and corrective and preventive actions. Furthermore, the firm failed to document critical design control activities, including design validation, verification, inputs, reviews, and plans for their anoscope products.