USFDA issues Form 483

New Delhi: Marksans Pharma Ltd on Thursday said the US health regulator has issued a Form 483 with five inspectional observations after inspecting its manufacturing facility at Vema, in Goa. The US Food and Drug Administration (USFDA) had conducted a routine current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility from April 9-17, 2024, the company said in a regulatory filing. “On conclusion of the inspection, the company has received five inspectional observations in Form 483,” Marksans Pharma said.