Kumar Organic Products LimitedApril 21, 2023

FDA 483 - Kumar Organic Products Limited - April 21, 2023

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Record Details

An FDA inspection of Kumar Organic Products Limited in Vadodara, India, revealed a repeat observation concerning deficiencies in their materials system. The firm failed to adequately verify the reliability of component supplier's certificates of analysis, impacting products shipped to the United States. This indicates a significant issue with supplier qualification and quality control.

Company: Kumar Organic Products Limited
Inspection Date: April 21, 2023
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Patty P. Kaewussdangkul (Investigator)

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