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.
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.
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.
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