The FDA slammed three Indian drugmakers with Form 483s following recent inspections that uncovered unsanitary conditions, broken equipment and poor recordkeeping. Mumbai-based Alkem Labs was cited ...

The latest Form 483 represents the second recent FDA citation for Zydus. Last month, the agency posted another Form 483 issued after a March inspection of Zydus’ facility in Matoda, India.

Importantly, FDA also states that timely Form FDA 483 responses that include “appropriate corrective and preventive actions could impact FDA’s determination of the need for subsequent Agency ...

In the 2024 Form 483s, the FDA deemed certain of the company’s devices, including cranial perforators, disposable cottonoid patties, strips, and collagen-based products, to be out of compliance ...

The inspection concluded with a Form 483 containing several observations. Capricor said it has submitted its responses to the FDA, none of which required material changes to the cGMP process or ...

No. 2:21-cv-00561-BSJ provides helpful guidance on liability under the federal securities laws in cases involving a Form 483 inspection by the Food & Drug Administration (“FDA”). 1 BACKGROUND ...

The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. The NECC is under investigation for contaminated products ...

A Form 483 is issued by USFDA inspectors to the management of the company at the end of an onsite inspection if inspectors find any violations of the Food, Drug and Cosmetic (FD&C) Act or other ...

Dr Reddy's Laboratories received a Form 483 with seven observations from the USFDA for its Srikakulam-based plant in Andhra Pradesh. The inspection, conducted from July 10 to 18, 2025, highlighted ...