Kumar Organic Products Ltd.June 13, 2025

FDA 483 - Kumar Organic Products Ltd. - June 13, 2025

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Record Details

Kumar Organic Products Ltd in Bangalore, India, an API manufacturer, was cited for significant quality control deficiencies during an FDA inspection. Observations included failures in quality unit responsibilities, inadequate OOS investigations and CAPAs, deficient complaint handling, poorly maintained manufacturing equipment, and an insufficient cleaning validation program. These issues indicate a systemic breakdown in ensuring product quality and safety.

Company: Kumar Organic Products Ltd.
Inspection Date: June 13, 2025
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Jose M. Cayuela

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