Friday, March 1, 2019

Indian drug makers show improvement in USFDA inspection outcomes

Indian drug makers show improvement in USFDA inspection outcomes According to USFDA data, out of 174 inspections in 2018 only 4 percent inspections are classified as OAI, attracting agency’s regulatory and administrative action such as withholding new approvals, warning letter and import alert, in contrast to 15 percent in 2017.

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