483
Vimta Labs, LimitedVimta Labs, Limited – FDA 483, Aug 16, 2019
Record Details
An FDA inspection of Vimta Labs Ltd. in Hyderabad, India, revealed a significant failure to maintain adequate case histories for subjects enrolled in two bioequivalence studies. The firm did not ensure that all subjects had readable chest X-rays, a critical requirement specified in their ethics committee-approved protocols. This indicates a serious deficiency in data integrity and adherence to study protocols.
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ID · 7e6fae6b-de6a-4948-91f9-28e1d949ff0e
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