Dr. Reddy's Laboratories LtdOctober 25, 2019

FDA 483 - Dr. Reddy's Laboratories Ltd - October 25, 2019

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An FDA inspection of Dr. Reddy's Laboratories Ltd CTO SEZ Process Unit-01, an API manufacturer, revealed significant deficiencies. Observations included inadequate investigations into potential root causes, insufficient evaluation of cleaning processes for non-dedicated equipment, and improper storage of production equipment. Additionally, the Quality Unit demonstrated a lack of oversight regarding manufacturing equipment.

Company: Dr. Reddy's Laboratories Ltd
Inspection Date: October 25, 2019
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Dipesh K. Shah

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