483
Torrent Pharmaceuticals LimitedFDA 483 - Torrent Pharmaceuticals Limited - April 16, 2019
Record Details
Torrent Pharmaceuticals Limited received a Form 483 citing significant deficiencies in quality control and manufacturing processes. Observations included failures in thoroughly investigating out-of-specification results, lack of adequate written procedures for process controls, and deficient routine calibration and qualification of manufacturing equipment. These issues indicate a systemic breakdown in ensuring product quality and compliance.
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ID · 32b739d4-b55c-4f77-9cf6-595e6bbeea6f