FDA 483 - Controltek, Inc. - December 20, 2019

An FDA inspection of Controltek, Inc., a medical device contract manufacturer in Vancouver, WA, from December 16-20, 2019, identified significant deficiencies in their quality system. The firm failed to adequately establish procedures for device history records, corrective and preventive actions, and process controls, indicating a systemic lack of documentation and oversight in critical manufacturing operations.