US FDA during its inspection, reviewed the certification reports for manufacturing of Carvedilol and aramomycin.
The US FDA has issued operational clearence, based on the corrective actions taken by Caraco with regard to Form 483, which is used by the FDA to document issues discovered during plant inspections.
Caraco, as of now, can only produce Carvedilol and aramomycin, according to Sun Pharma.
Detriot and Wixom sites are prohibited from manufacturing other products, including those awaiting US FDA approval.
Caraco is also required to work with an external auditor conducting regular inspections for an extended period with reference to other requirements of the same Consent Decree, 483.