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Strides Pharma gets 3 observations from USFDA for Bangalore plant


Strides Pharma gets 3 observations from USFDA for Bangalore plant

The company believes that the observations are not material in nature and have already responded to the USFDA, it added.

New Delhi: Drug firm Strides Pharma Science 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, Form 483 is issued to a firm’s management at the conclusion of an inspection when an 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.



Source: PTI
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