Dexcom receives FDA warning letter for two manufacturing sites
The warning letter follows inspections by the FDA at Dexcom’s manufacturing facilities in San Diego and Mesa, Ariz., and ...
Dexcom receives FDA warning letter for two U.S. manufacturing facilities
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
Business Wire2d
LGM Pharma Invests $6M in U.S. Drug Manufacturing Capabilities for Liquids, Suspensions, Semi-Solids, and Suppositories
The investment of over $6 million will expand LGM Pharma’s Rosenberg, Texas manufacturing facility as part of its Phase I ...
Fierce Biotech4d
Dexcom receives FDA warning letter over CGM manufacturing issues
Dexcom has received a warning letter from the FDA, after the agency uncovered issues during two inspections of the continuous ...
Fierce Pharma9d
Granules slammed in FDA warning letter detailing discarded documents, intruding birds at Indian plant
Shortly after making an M&A play to break into the CDMO business, Granules’ manufacturing bona fides have come under fire in ...
MedTech Dive4d
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 ...
Medscape2d
Compounders Face Deadline to Stop Manufacturing Tirzepatide
The Outsourcing Facilities Association is appealing a ruling that rejected their request for an injunction against the FDA’s ...
Drug Delivery Business4d
Dexcom receives FDA warning letter
Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.
As tariffs loom over pharma manufacturing, a reshoring effort is underway — but not without challenges
However, for generic drug makers, which are hardest hit by Chinese tariffs, slim profit margins and high costs may thwart ...