Express Pharma

Shilpa Med gets 10 observations from US FDA

5

The facility is located at Jadcherla in Telangana

Shilpa Medicare 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 (US FDA) 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 practises, three observations are related to setting of analytical specifications, test procedures and method validation, Shilpa Medicare said.

As per the US FDA, 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.

Comments are closed.