The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
A Form 483 is a type of agency report containing "observations" that FDA inspectors "deem to be objectionable." Dexcom ...
Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls ...
The FDA cited issues with DexCom's response to prior inspection findings, known as Form 483 observations. The inspections took place at the San Diego facility between October 21 and November 7, 2024, ...
Dexcom announced today that it received a warning letter from the FDA following inspections of two company facilities.
Alembic Pharmaceuticals stated that the United States Food and Drug Administration (US FDA) had conducted an inspection at the company's bioequivalence facility located at Vadodara from 3rd to 7th of ...
In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections ...
The inspection took place at the company’s sterile API manufacturing unit in Visakhapatnam, located in Jawaharlal Nehru Pharma City (JNPC).
The filing further read the company will provide a comprehensive response to US FDA for the observations within the ...
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 ...
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 ...
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