Drug firm Strides Shasun today said the US health regulator has issued 3 observations after inspecting its formulations facility in Bangalore. “The formulations facility in Bangalore was recently inspected by the US FDA. The company has been issued a Form 483 with 3 observations,” Strides Shasun said in a BSE filing.
“None of these observations relate to data integrity and quality control. The company will address the observations comprehensively,” it further said.
As per the US FDA, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.
The US FDA Form 483 notifies the company’s management of objectionable conditions. Strides Shasun shares were trading 2.42 per cent lower at Rs 895.50 apiece on the BSE.