Strides Shasun has said the US health regulator has issued three observations after inspecting its formulations facility in Bengaluru.
“The formulations facility in Bengaluru was recently inspected by the USFDA. The company has been issued Form 483 with 3 observations,” Strides Shasun said in a BSE filing today.
“None of these observations relate to data integrity and quality control. The company will address the observations comprehensively,” it further said.
As per the USFDA, 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 USFDA 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.