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.

FDA puts New Jersey drug ingredients maker Spectrum through the wringer in scathing Form 483 By Fraiser Kansteiner Oct 11, 2023 3:28pm U.S. FDA Form 483 Manufacturing Facilities quality control ...

The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass.

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

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 ...

InvestingPro Insights Recent data from InvestingPro sheds additional light on Humacyte's financial situation and market performance. Despite the uncertainty surrounding the FDA's Form 483 findings ...

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.

However, Humacyte's stock has faced headwinds following recent FDA inspections and a Form 483 letter citing quality control concerns.

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 ...

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 ...