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Shilpa Medicare gets 10 observations from USFDA for Jadcherla plant


Shilpa Medicare gets 10 observations from USFDA for Jadcherla plant

New Delhi: Drug firm Shilpa Medicare said it has received 10 observations from the US health regulator for its formulation facilities at Jadcherla in Telangana.

The company “has received 483 observations from the United States Food and Drug Administration (USFDA) in relation to SEZ formulation facilities situated at Jadcherla, Telangana,” Shilpa Medicare said in a filing to the BSE.

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

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

As per the USFDA, 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 FDA Form 483 notifies the company’s management of objectionable conditions.



Source: PTI
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