483
Sun Pharmaceutical Industries LimitedSun Pharmaceutical Industries Limited – FDA 483, Feb 7, 2020
Record Details
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.
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ID · 79501485-3d89-4a81-a5e5-74e78330b880
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