Key Takeaways
- DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.
- The maker of glucose monitoring devices said investigations of its San Diego, Calif., and Mesa, Ariz., facilities discovered “non-conformities” in manufacturing and quality management system.
- DexCom said the letter won’t impact operations and results.
Shares of DexCom (DXCM) sank 6% Monday after the maker of glucose monitoring devices reported it had received a warning letter from federal regulators over the condition of two of its manufacturing plants.
The company said the letter from the Food and Drug Administration (FDA) noted “deficiencies in the response” from DexCom to the FDA’s Form 483, which outlines observations from investigators.
The company noted the FDA held inspections of its San Diego, Calif., and Mesa, Ariz., facilities last year, which found “non-conformities in manufacturing processes and quality management system.”
DexCom explained that it has “already submitted several responses to the Form 483 and is in the process of preparing a written response to the warning letter.” It added that it plans “to continue to undertake certain corrections and corrective actions,” although cannot guarantee the FDA will be satisfied with the response by the deadline regulators have set.
DexCom Says It Expects No Material Impact From Warning Letter
The company pointed out that its operations are not being affected and it sees no material impact from the warning letter.
Separately, DexCom announced that it had named Renée Galá to its board of directors. Galá is currently President and COO of Jazz Pharmaceuticals (JAZZ).
DexCom shares have lost about 45% of their value over the past year.
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