Sun Pharmaceutical Industries LimitedFebruary 7, 2020

FDA 483 - Sun Pharmaceutical Industries Limited - February 07, 2020

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An FDA inspection of Sun Pharmaceutical Industries Limited in Mohali, India, revealed a significant issue with drug product testing. The firm failed to appropriately test batches of non-sterile drug products for objectionable microorganisms, specifically using unvalidated methods for method suitability tests. This indicates a serious lapse in quality control for products shipped to the United States market.

Company: Sun Pharmaceutical Industries Limited
Inspection Date: February 7, 2020
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Philip F. Istafanos
Jeffrey P. Raimondi (Consumer Safety Officer)

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ID · 79501485-3d89-4a81-a5e5-74e78330b880