Sun Pharmaceutical Medicare Limited – FDA 483, Feb 5, 2019
An FDA inspection of Sun Pharmaceutical Medicare Limited in Halol, Gujarat, a pharmaceutical manufacturer, revealed a significant issue regarding the firm's failure to thoroughly review unexplained discrepancies and out-of-specification (OOS) results. The firm repeatedly invalidated OOS re-dispersibility test results by attributing them to human error during sample preparation without adequate supporting evidence. This indicates a serious lapse in quality control and investigation procedures.
ID · 9f8de95a-40c8-475d-ac17-75f6b3f155fe
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