Healthcare Packaging7m
FDA Warning Letters: The Do's and Don'ts on How to Respond
Do: Respond within 15 business days of the original letter and be specific in that response. “It’s important to critically ...
Drug Delivery Business3d
Dexcom receives FDA warning letter
Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.
Read the resignation letter from FDA food director Jim Jones
Jim Jones, director of the Food and Drug Administration’s food division, slammed the “indiscriminate firing” of dozens of his ...
National Law Review4d
FDA Issues FSVP-Related Warning Letters
Both warnings letters were issued after multiple inspections and following failures to respond to FDA 483a forms issued at ...
Top FDA food safety official's resignation letter warns firings will backfire on RFK Jr.
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." ...
MedTech Dive3d
Dexcom receives warning letter based on FDA inspections of 2 plants
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
Exclusive: FDA staff reviewing Musk’s Neuralink were included in DOGE employee firings, sources say
U.S. Food and Drug Administration employees reviewing Elon Musk’s brain implant company Neuralink were fired over the weekend ...