483
Steriscience Specialties Private LimitedSteriscience Specialties Private Limited – FDA 483, Feb 14, 2019
Record Details
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.
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ID · 8abbc69f-97aa-4f0f-a22d-68df1a7635ab
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