FDA 483 - Dr. Reddy's Laboratories Ltd. - May 17, 2024

An FDA inspection of Dr. Reddy's Laboratories Ltd. in Duvvada, India, a parenteral drug manufacturer, revealed significant deficiencies in preventing microbial contamination of sterile drug products. Observations included a lack of aseptic transfer procedures, inadequate smoke studies, and insufficient root cause analysis for fungal excursions. Additionally, the firm failed to properly clean, maintain, and sanitize equipment and storage tanks, leading to potential contamination risks.