FDA finds "routine fabrication" of safety data at Indian CDMO

The US medicines regulator has issued a warning letter to Indian contract development and manufacturing organization (CDMO) Brassica Pharma for severe data integrity violations at its manufacturing facility in Thane.

Based in Maharashtra, Brassica specializes in the production of sterile ophthalmic ointments, gels, and prefilled syringes, serving various therapeutic areas including eye care, skincare and wound care.

Among the most critical issues noted by the Food and Drug Administration (FDA) were failures in sterility testing, environmental monitoring, and data fabrication.