"The company's API and intermediates manufacturing facility located at Jigani, Bangalore, was recently inspected by the United States Food and Drug Administration (USFDA) in compliance with their requirements," Hikal Ltd said in a filing to BSE.
At the end of the successful inspection, the company has been informed by the investigator that 'zero' 483 observations were issued, it added.
The FDA Form 483 notifies the company's management of objectionable conditions. It is issued at the conclusion of an inspection when investigators observe any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.