Dr. Reddy's Laboratories Receives FDA Form 483 With Two Observations

May 27, 2025 at 10:36 AM IST

Dr. Reddy's Laboratories Ltd reported receiving a Form 483 from the US FDA following an inspection of its active pharmaceutical ingredient facility CTO-5 in Miryalaguda, Telangana. The inspection took place from May 19 to May 24.

The FDA issues Form 483 to management when it observes conditions that may indicate potential violations of the Food, Drug, and Cosmetic Act or related regulations. Dr. Reddy's reported two such observations