Receives 10 observations under Form 483
Shilpa Medicare has received 483 Observations from the United States Food & Drug Administration (USFDA) in relation to SEZ Formulation Facilities situated at Jadcherla, Telangana (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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