Dr. Reddy's Laboratories Ltd. – FDA 483, Aug 14, 2026
An FDA inspection of Dr. Reddy's Laboratories Ltd. in Medchal-Malkajgiri District, Telangana, India, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to conduct thorough investigations into product defects and deviations, maintain adequate laboratory controls, and adhere to established timelines for out-of-specification investigations. Additionally, manufacturing records lacked complete instructions, leading to high variability in critical process steps.
ID · 272efcfa-30b9-49a8-b265-3888dd523c43
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