USFDA inspects Spain plant of Vivimed, no observations issued

Drug firm Vivimed Labs today said US health regulator has recently inspected its manufacturing plant in Spain without making any observations.

"The company's active pharmaceutical ingredient (API) manufacturing facility in Sant Celoni, Spain was recently inspected by the United States Food and Drug Administration (USFDA)", Vivimed Labs said in a BSE filing.

At the end of the successful inspection, 'zero' 483 observations were issued, it added.

As per the USFDA, an FDA Form 483 is issued to firm management at the conclusion of an inspection when investigator(s) have observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
 

Shares of Vivimed Labs today closed 2.42 per cent lower at Rs 105.05 per scrip on BSE.