Drug firm Strides Pharma Science Tuesday said the US health regulator has issued three observations after inspecting its formulations facility in Bangalore.
"The formulations facility in Bangalore recently underwent pre-approval product inspection by the US Food and Drug Administration(USFDA). The inspection ended on August 25, 2018 and the company has been issued a Form 483 with 3 observations," Strides Pharma Science said in a regulatory filing.
The company believes that the observations are not material in nature and have already responded to the USFDA, it added.
It has recently received a product approval for Potassium Chloride extended release tablets from the facility, the company said.
As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
It notifies the company's management of objectionable conditions.
Strides Pharma Science shares today ended 1.89 per cent down at Rs 499.10 apiece on the BSE.
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