Indoco Remedies receives Establishment Inspection Report for Unit II & III in Goa
Indoco Remedies has received the Establishment Inspection Report (EIR), from the US Food and Drug Administration (USFDA) for its sterile facility (Plant II) and solid dosages facility (Plant III) at Verna, Goa for the inspection carried out between 7 October to 15 October, 2019. This was a Pre-Approval Inspection for a sterile injectable product, with 2 observations on Form 483s, which is now concluded as closed.
The inspection classification of this site has been determined as VAI (Voluntary Action Indicated) by the USFDA.
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First Published: Nov 25 2019 | 9:11 AM IST