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 its ...
Jiangsu Hengrui Pharmaceuticals and its partner Elevar Therapeutics will have to wait even longer before their PD-1 inhibitor ...
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 ...
Indian pharmaceutical giant Biocon on Wednesday told the BSE that the US-FDA (Food and Drugs Administration) has issued a Form 483 with six observations for its manufacturing facility in Malaysia.
"The said inspection was concluded with three Form 483 Observations. These observations are procedural in nature," it added. The corrective and preventive actions for these observations will be ...
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 ...
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 ...
related to concerns about manufacturing processes and quality management systems. The FDA cited issues with DexCom's response to prior inspection findings, known as Form 483 observations. The ...
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., ...
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 ...
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