FDA 483 - Steriscience Specialties Private Limited - February 14, 2019

An FDA inspection of Mylan Laboratories Limited in Bangalore, India, identified a significant issue with equipment design. Particulate matter was found in retention samples of drug products, linked to a component used in the filling process. The firm failed to conduct an in-use study to demonstrate that this component does not introduce unacceptable levels of particulates into the product.