FDA 483 - Torrent Pharmaceuticals Limited - June 12, 2024

Torrent Pharmaceuticals Limited, an API and finished product manufacturer in Indrad, Gujarat, India, received five observations during an FDA inspection. Key findings include a deficient stability testing program, failure to thoroughly investigate out-of-trend and out-of-specification results, and inadequate equipment cleaning procedures. These issues indicate significant concerns regarding drug product quality, safety, and overall quality system oversight.