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Strides Shasun gets 3 observations from USFDA for Bangalore plant


Strides Shasun gets 3 observations from USFDA for Bangalore plant

New Delhi: Drug firm Strides Shasun 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.

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Ruby Khatun

Ruby Khatun

Ruby Khatun joined Medical Dialogue as Reporter in 2016. She covers all the business news in different categories. She also covers all the updates in Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a post graduate from Jamia Hamdard. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751


Source: PTI
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