FDA 483 - Carrot Medical, LLC - December 12, 2019

Carenet Medical, LLC, a manufacturer in Bothell, WA, was inspected by the FDA, revealing a significant issue with the firm's training procedures. The inspection found that the company failed to adequately establish and document employee training, including updates to training syllabi and specific training for Field Service Engineers. This indicates a lack of proper control over personnel qualifications and training records.