DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.

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

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 ...

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 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 ...

Last month, US FDA had issued Form 483 with two observations after the inspection conducted at its formulations manufacturing facilities (FTO-7 & FTO-9) in Duvvada, Visakhapatnam, Andhra Pradesh.

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 ...

The agency posted the letter to its website Tuesday. Granules previously received and responded to an FDA Form 483 following the agency’s visit to the plant from Aug. 26 to Sept. 6, 2024.

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.