Sun Pharmaceutical Medicare LimitedFebruary 5, 2019

FDA 483 - Sun Pharmaceutical Medicare Limited - February 05, 2019

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Record Details

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.

Company: Sun Pharmaceutical Medicare Limited
Inspection Date: February 5, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Tamil Arasu (Consumer Safety Officer - Dedicated Foreign Drug Cadre)

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ID · 9f8de95a-40c8-475d-ac17-75f6b3f155fe