Arizona related to concerns about manufacturing processes and quality management systems. The FDA cited issues with DexCom’s ...

DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.

In the warning letter, the FDA cited deficiencies in the response ... non-conformities in manufacturing processes and quality management system. The warning letter does not restrict the company ...

The warning letter identified issues in manufacturing processes and quality management system at Dexcom's facilities ... containing "observations" that FDA inspectors "deem to be objectionable." ...

Zhejiang Langhua Pharmaceutical Co., Ltd. ('Langhua Pharmaceutical'), a wholly-owned subsidiary of Viva Biotech Holdings ('Viva Biotech'), underwent a cGMP (Current Good Manufacturing Practices) ...