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Shilpa Medicare update on USFDA inspection of facility at Jadcherla, Telangana

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Receives 10 observations under Form 483

has received 483 Observations from the United States Food & Drug Administration (USFDA) in relation to SEZ Formulation Facilities situated at Jadcherla, (near Hyderabad) as under;

a) Total 10 observations were cited during the close up meeting.
b) 7 observations are improvement in procedures and practices.
c) 3 observations are related to setting of analytical specifications, test procedures and method validation.

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

First Published: Wed, December 06 2017. 09:57 IST
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