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 ...

Key Takeaways DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.The maker of glucose monitoring devices said investigations of its San ...

SAN DIEGO – Dexcom has received a warning letter from the U.S. Food and Drug Administration regarding “non-conformities” in manufacturing and quality processes after inspections of its facilities ...

Jiangsu Hengrui Pharmaceuticals and its partner Elevar Therapeutics will have to wait even longer before their PD-1 inhibitor ...

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 ...

The new admonition came after the FDA found deficiencies in Dexcom’s response to the inspections’ official list of observations, known as a Form 483. According to the agency, some of those ...

the FDA cited deficiencies in the response letters sent by the company to the FDA following the Form 483, List of Investigational Observations, which was delivered to the company in connection ...

New Delhi Emcure Pharmaceuticals on Wednesday said the US health regulator has issued two observations after inspecting its Pune-based active pharmaceutical ingredients (API) manufacturing facility.