Warning on Dexcom CGM manufacturing
The FDA sent a warning letter about methods used in the manufacture, packing, storage, or installation of the G6 and G7 continuous glucose monitors (CGMs).
The FDA recently announced that a warning letter was sent to Dexcom, Inc., stating that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the G6 and G7 continuous glucose monitors are not in conformity with the current good manufacturing practice requirements of the Quality System regulation. Violations included inadequate process monitoring and test validation.