The FDA has found problems at an Indian factory that makes generic drugs for American patients, including one medication that ...

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 ...

Some observations: 1. The Court’s ruling is no ... s position has been that the Comstock Act “is not relevant to FDA’s exercise of its authority under the FDCA [Food, Drug, and Cosmetic ...

FDA inspectors visited Dexcom’s facility in Mesa, Arizona, in June and its San Diego site in October and November. The ...

When the primary use of a product is an unlabeled use -- an indication not listed in the FDA-approved labeling -- it can be especially difficult to get information about a shortage. Manufacturing ...

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, ...

Generic injectable-focused Gland Pharma facility in Visakhapatnam has been issued three observations by the U.S. Food and Drug Administration (U.S. FDA). U.S. FDA issues 3 observations to Gland ...

It has not indicated any further escalation, Granules said. Significant progress has been made to address all of the FDA observations across the four areas with most corrective actions completed ...

The company is confident of addressing these observations expeditiously and will respond to the FDA with a corrective and preventive action plan (CAPA) in a timely manner, the spokesperson said.

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 ...