Dexcom Receives FDA Warning Letter for Two U.S. Manufacturing Facilities
Dexcom has received a warning letter from the FDA following inspections of its two key manufacturing facilities, identifying issues with manufacturing processes and quality management systems in San Diego, California, and Mesa, Arizona. The company had already submitted responses to the Form 483 report and is preparing a written response, which it does not expect to have a material impact on manufacturing capacity or sales guidance for fiscal year 2025. Dexcom manufactures its products at multiple facilities worldwide, including its headquarters in San Diego, California.
- This incident highlights the critical importance of regulatory oversight in ensuring the quality and safety of medical devices, particularly those that require precise manufacturing processes.
- What steps will Dexcom take to address these quality control issues, and how will this impact consumer trust and confidence in the company's products?