NEW DELHI: India’s top drug maker Sun Pharmaceutical Industries has received a rap from the United States regulator for being lax in monitoring the follow-up corrective actions for the drugs it recalled from the US market early this year.
The company has not put in place a proper formalised corrective and preventive action plan for the diabetes drug (Metformin extended release) it recalled, the US Food & Drug Administration investigators noted after inspecting Sun Pharma’s Halol plant in Gujarat last month, according to a copy of form 483 reviewed by ET. The form is used by the FDA to document concerns discovered during its inspections.
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