Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.
Jim Jones, director of the Food and Drug Administration’s food division, slammed the “indiscriminate firing” of dozens of his ...
Both warnings letters were issued after multiple inspections and following failures to respond to FDA 483a forms issued at ...
James Jones resigned as FDA deputy commissioner and said the Trump administration's "indiscriminate" job cuts show "disdain for the very people necessary to implement your agenda." ...
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
Last year, the FDA gave that device a designation aimed at speeding up development and federal review, the company has said. The dismissal letters sent to the FDA reviewers cited performance ...