The FDA Finally Visited an Indian Drug Factory Linked to U.S. Deaths. It Found Problems.
The inspection comes after a ProPublica investigation revealed that drugs made at the Glenmark Pharmaceuticals plant ...
Alembic Pharma down 3% on getting USFDA observation for its Vadodara plant
The filing further read the company will provide a comprehensive response to US FDA for the observations within the ...
MedTech Dive12d
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 ...
CNBCTV189d
Alkem Laboratories' Bioequivalence Center clears US FDA inspection without observations
Pharmaceutical company Alkem Laboratories Ltd on Thursday (March 13) announced that the United States Food and Drug ...
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 ...
The Hindu25d
U.S. FDA issues three observations to Gland Pharma’s Vizag unit
Generic injectable-focused Gland Pharma facility in Visakhapatnam has been issued three observations by the U.S. Food and Drug Administration (U.S. FDA). U.S. FDA issues 3 observations to Gland ...
Yahoo Finance13d
Dexcom receives warning letter based on FDA inspections of 2 plants
FDA inspectors visited Dexcom’s facility in Mesa, Arizona, in June and its San Diego site in October and November. The inspections generated a Form 483 that listed observations the FDA made ...
The Hindu23d
U.S. FDA issues warning letter to Granules unit in Hyderabad
It has not indicated any further escalation, Granules said. Significant progress has been made to address all of the FDA observations across the four areas with most corrective actions completed ...
health.economictimes.indiatimes14d
Dexcom receives FDA warning letter for two U.S. manufacturing facilities
A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable." Dexcom manufactures its products at its headquarters in San Diego, California and at ...