Sun Pharmaceutical Industries announced that subsequent to inspections earlier this year and corrective action on 483’s, US FDA has determined Caraco to be in compliance with relevant paragraphs of the Consent Decree. Therefore, US FDA has notified that Caraco may resume operations at its manufacturing facility and packaging sites in Detriot and Wixom, Michigan. During their inspection, the US FDA reviewed the certification reports for production of Carvedilol USP as well as Paramomycin USP, and subsequently reviewed corrective actions on 483’s. Currently, Caraco may resume products of only these two products.
Manufacturing of other products from these sites, including those pending approval with the US FDA, will be subject to similar rigorous approval procedure. As a result, the increase in production at these sites and resultant revenue contribution is expected to be gradual.
With reference to other requirements of the same Consent Decree, Caraco is required to now work with an external auditor conducting regular inspections for an extended period.
EP News Bureau
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