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

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 ...

The observations were issued on Friday after the US drugs watchdog wrapped up its inspection of the Eugia facility, Unit-III, that is located on the outskirts of Hyderabad. The inspection was ...

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 ...

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 ...

A Form-483 with six observations was issued by the U.S. FDA after the General GMP inspection of the facility from February 11-17. The observations are largely around improvement of procedures and ...

The filing further read the company will provide a comprehensive response to US FDA for the observations within the ...

Alkem Laboratories announced that the United States Food and Drug Administration (USFDA) conducted a Bioresearch Monitoring (BIMO) inspection at its Bioequivalence Center in Taloja, Maharashtra, from ...

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 ...

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 ...