Generics maker Caraco says that, even assuming a smooth remediation process, it will take "significant time" before its Detroit facility is back up to pre-consent-decree production levels.
Under the consent decree agreement, the drugmaker can resume manufacturing only after completing "significant [remediation] steps and processes," according to an announcement, and then obtaining certification by the regulator and a third party.
Caraco says it's well along the remediation path with its first two products and expects to resume manufacturing minimal volumes in the Detroit plant by the end of fiscal 2011. It expects to produce minimal volumes of two or three additional products in the fiscal 2012 third quarter. Contract manufacturers will augment Caraco's output.
The consent decree stretches back to September 2009 and stems from unresolved GMP violations. Three months earlier, federal marshals seized 33 medications and drug ingredients at Caraco plants in Detroit, Farmington Hills and Wixom. The seizure follows a series of product recalls stemming from manufacturing defects.
Caraco includes the remediation update in an announcement of G. P. Singh Sachdeva's naming to the post of CEO following the resignation of Jitendra Doshi, who was named interim CEO and a director in July 2009. And in doing so, it illustrates the extent to which a consent decree can change a business-oriented executive agenda to one of operations. The announcement cites Doshi's efforts in the company's remediation activities, and it says Sachdeva will be "assisted by our talented team in working towards completion of our remediation efforts and resumption of operations."
- see the Caraco release