Steriscience Specialties Private LimitedFebruary 14, 2019

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

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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.

Company: Steriscience Specialties Private Limited
Inspection Date: February 14, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Nicholas A. Violand (Director, Enterprise Regulatory Compliance)
Bijoy Panicker

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ID · 8abbc69f-97aa-4f0f-a22d-68df1a7635ab