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.

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 FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. Advertisement. Jaimie Oh Monday, October 29th, 2012. Print ...

For a pharmaceutical company, a clean FDA inspection report is crucial for maintaining and expanding its presence in global markets ...

The US drug regulator has completed a pre-approval inspection at Emcure’s Ahmedabad oncology facility without issuing a Form ...

Emcure Pharma share price rose in trade after the company announced that United States Food and Drug Administration (USFDA) ...

On Friday, BTIG reaffirmed its Buy rating and $10.00 stock price target for Humacyte (NASDAQ:HUMA) following the release of a Form 483 from the FDA.

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, ...

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 ...

FDA's Form 483 inspection report raised significant quality control concerns. Key Points: Upcoming earnings expected to report EPS of -$0.25, unchanged year-over-year.

On Friday, BTIG reaffirmed its Buy rating and $10.00 stock price target for Humacyte (NASDAQ:HUMA) following the release of a Form 483 from the FDA. The form, which details findings from facility ...