Dexcom Hit With Warning After 2 Inspection

Dexcom says it was issued on 3/4 an FDA Warning Letter following inspections at the company’s facilities in San Diego, CA and Mesa, AZ. The letter cited deficiencies contained in response letters sent by Dexcom after receiving Form FDA-483 from the inspections.

“The Warning Letter describes observed non-conformities in manufacturing processes and quality management system,” Dexcom says. The agency is not restricting the company’s ability to produce, market, manufacture or distribute products, requiring a recall of any products, nor restricting its ability to seek FDA 510(k) clearance of new products, it says.

Dexcom says it is preparing a written response to the Warning Letter, and it intends to continue to undertake certain corrections and corrective actions. It will also continue to provide regular updates to FDA in response to the Form 483.