Torrent Pharma Faces USFDA Observations Post Gujarat Plant Inspection

Torrent Pharmaceuticals received a Form 483 with five observations from the USFDA after an inspection of its Gujarat manufacturing plant. The inspection, held from June 3 to June 12, covered pre-approval and GMP standards. The company plans to address the observations swiftly and ensure compliance.

Torrent Pharmaceuticals has been issued a Form 483 with five observations by the US Food and Drug Administration (USFDA) following an inspection of its manufacturing facility in Indrad, Gujarat.

Conducted between June 3 to June 12, the inspection included both pre-approval and Good Manufacturing Practice (GMP) checks.

Importantly, Torrent Pharmaceuticals indicated that there were no observations related to data integrity. The company assured stakeholders that it would respond to the USFDA within the prescribed timeframe and collaborate closely to address the points raised as soon as possible.