www.fdanews.com/articles/179686-sun-pharmaceuticals-halol-plant-still-in-trouble-with-fda-after-new-report
Sun Pharmaceuticals Halol Plant Still in Trouble with FDA after New Report
December 13, 2016
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.