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 ...
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 ...
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 ...
Canned tuna recall: FDA updates risk level for products sold at major retailers, including Costco, Walmart
The U.S. Food and Drug Administration (FDA) posted a notice in February that Tri-Union Seafoods is recalling select lots of ...
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 ...
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 ...
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.