Troy Innovative Instruments IncJuly 26, 2024

FDA 483 - Troy Innovative Instruments Inc - July 26, 2024

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Record Details

Troy Innovative Instruments Inc., a medical device contract manufacturer, was cited for significant quality system deficiencies including inadequate control of non-conforming products, insufficient documentation of corrective and preventive actions, and failures in maintaining complaint files. The inspection also revealed a lack of clear controls over suppliers and infrequent management reviews of the quality system.

Company: Troy Innovative Instruments Inc
Inspection Date: July 26, 2024
Product Type: Device
Office: Cincinnati District Office
Person: Benjamin J. Dastoli (Investigator )

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ID · 7901f3e5-2fc2-4bda-859c-4c099557f67c