Sun Pharmaceuticals Halol Plant Still in Trouble with FDA after New Report

A year after receiving a warning letter, Sun Pharmaceuticals’ Halol, India plant has been hit with another Form 483.

That warning letter, issued in December 2015, contained a litany of serious violations, including inadequate written procedures, unexplained failures of drug batches and failures to maintain a clean area in aseptic processing.

The FDA also asked for a new smoke studies, repairs of leaking ceilings and details on how the company planned to redesign its aseptic processing operation.