Dr. Reddy’s Nailed Again for Facility Slipups

Dr. Reddy’s inspection woes continue following the FDA’s inspection of its Indian API manufacturing plant in Bollaram, Hyderabad, which revealed multiple violations and netted the pharma giant yet another Form 483.

Marking its fourth 483 this year, the agency’s thrashing follows a 483 issued for its Visakhapatnam, Andhra Pradesh site and the company’s February disclosure of a 483 for its Bachupally, Hyderabad facility. It was also disciplined in January for violations at its Srikakulam, Andhra Pradesh plant.

During its July 8-12 inspection, the agency noted that the firm received several complaints from customers about out-of-specification results they got after performing API tests on products they bought.