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 ...

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

Enhance FDA compliance with our expanded training on inspection processes, common issues, and strategies for prevention. Gain insights into Form 483 and warning letter prevention, root cause analysis, ...

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

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.

HYDERABAD: Pharma major Dr Reddy’s Laboratories on Saturday said its active pharmaceutical ingredients manufacturing facility at Middleburgh in New York has been issued a Form 483 with two ...

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 ...

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 ...