FDA 483 - Dexcom, Inc. - September 17, 2021

Dexcom, Inc., a medical device manufacturer in San Diego, CA, was inspected by the FDA from August 30 to September 17, 2021. The inspection revealed inadequate procedures for receiving, reviewing, and evaluating customer complaints. Specifically, the firm failed to document complaint records for customer inquiries related to skin reactions, despite having internal classification codes for such events.