An FDA inspection of Marksans Pharma’s main manufacturing facility in Goa, India revealed multiple packaging violations.

The agency’s investigators found that the quality unit didn’t review or approve repackers used for packaging products meant to be sold in the U.S.

The company’s quality agreements with repackers were flawed, as they didn’t define the packaging components or component suppliers and didn’t require Marksans to be notified if different packaging components were used, the agency said in a Form 483 inspection report.