The FDA Finally Visited an Indian Drug Factory Linked to U.S. Deaths. It Found Problems.
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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 ...
Business Insider1mon
FDA posts observations from AstraZeneca site inspection
The FDA posted to its site the observations made during an inspection of an AstraZeneca (AZN) manufacturing center that was conducted from May 30, 2024 to June 7, 2024, including manufacturing and ...
Yahoo Finance12d
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 ...
Medscape19d
Provisional Observations on Drug Product Shortages: Effects, Causes, and Potential Solutions
When the primary use of a product is an unlabeled use -- an indication not listed in the FDA-approved labeling -- it can be especially difficult to get information about a shortage. Manufacturing ...
The Hindu1mon
Piramal Pharma facility gets six U.S. FDA observations
A Form-483 with six observations was issued by the U.S. FDA after the General GMP inspection of the facility from February 11-17. The observations are largely around improvement of procedures and ...
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 ...
The Hindu24d
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 Finance14d
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 ...