FDA 483 - Somerset Therapeutics Limited - February 19, 2020

Wintac Limited, a sterile drug manufacturer in Bangalore, India, was inspected by the FDA from February 10-19, 2020. The inspection revealed significant deficiencies in aseptic processing validation, microbiological contamination prevention, quality control unit procedures, and laboratory controls. Issues included inadequate media fill studies, lack of continuous environmental monitoring, problems with container/closure leachables, and insufficient investigation and CAPA implementation.