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 U.S. Food and Drug Administration 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.
As per U.S. FDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
There is no data integrity observation, it added.
The company will work closely with the USFDA and is committed to address these observations comprehensively within the stipulated time, the filing said.
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