Contech Medical, Inc.August 17, 2023

FDA 483 - Contech Medical, Inc. - August 17, 2023

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Record Details

An FDA inspection of Contech Medical, Inc., a contract manufacturer in Providence, RI, revealed two significant observations. The firm's procedures for controlling environmental conditions, specifically handling monitoring results and supporting corrective actions, were found to be inadequately established. Additionally, their complaint procedures lacked adequate provisions for reviewing, evaluating, and documenting investigation decisions.

Company: Contech Medical, Inc.
Inspection Date: August 17, 2023
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Wendy M. Stone (investigator)

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