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 company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
Indoco Remedies declined 3.22% to Rs 224.20 after its Clinical Research Organization, AnaCipher, located in Hyderabad, received one Form 483 from the United States Food and Drug Administration (US FDA ...
Medical Device Network on MSN12d
Analysts say Dexcom’s FDA warning unlikely to impact 2025 revenueDexcom was issued with an FDA warning letter after issues with “manufacturing processes and quality management systems.” ...
Hyderabad based AnaCipher, clinical research division of Indoco Remedies Ltd, US FDA (United States Food ... AnaCipher was issued one Form 483, which describes objectionable conditions observed ...
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
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 ...
Investopedia on MSN13d
DexCom Stock Drops as Diabetes Devices Maker Gets FDA Warning Letternoted "deficiencies in the response" from DexCom to the FDA's Form 483, which outlines observations from investigators. The ...
The filing further read the company will provide a comprehensive response to US FDA for the observations within the ...
Novo Nordisk’s weight loss drug Wegovy is linked to an increased risk of hair loss, a study suggests. Meanwhile, Dexcom ...
noted "deficiencies in the response" from DexCom to the FDA's Form 483, which outlines observations from investigators. The company noted the FDA held inspections of its San Diego, Calif., ...
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