Caraco Pharmaceutical Laboratories, the Detroit-based generic subsidiary of Sun Pharmaceuticals Ltd., has been issued a letter of warning by the US Food and Drug Administration (FDA), and all its future marketing approvals for medicines have been withheld due to some quality-control issues.
This action of the US regulator comes in the wake of certain technical inadequacies identified by it during a May 2008 inspection. The FDA considered some of its observations to be repeat observations, and hence issued the warning letter.
Caraco said the FDA observations include, among other things, the inadequate and untimely investigation by the quality control unit of certain incidents at the facility contrary to the company’s standard operating procedures.