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Shilpa Med gets 10 observations from USFDA for Jadcherla plant

Press Trust of India  |  New Delhi 

Drug firm today said it has received 10 observations from the US health regulator for its formulation facilities at Jadcherla in

The company "has received 483 observations from the United States Food and Drug Administration (USFDA) in relation to formulation facilities situated at Jadcherla, Telangana," said in a filing to the

Total 10 observations were cited during the close up meeting, it added.

While seven observations are regarding improvement in procedures and practises, three observations are related to setting of analytical specifications, test procedures and method validation, said.

As per the USFDA, observations are made in Form 483 when investigators feel that conditions or practises in the facility are such that products may become adulterated or render injuries to health.

The FDA Form 483 notifies the company's management of objectionable conditions.

of Shilpa Medicare today closed at Rs 635.15 per scrip on the BSE, down 0.24 per cent from its previous close.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Tue, December 05 2017. 18:10 IST