U.S. FDA issues 6 observations to Dr. Reddy’s biologics manufacturing facility in Hyderabad

The U.S. Food and Drug Administration (FDA) has issued five observations to the biologics manufacturing facility of generic drugmaker Dr. Reddy’s Laboratories in Hyderabad.

The observations followed a pre-approval inspection (PAI) of the facility in Bachupally, Hyderabad, the U.S. FDA conducted from September 4-12. “We have been issued a Form 483 with five observations, which we will address within the stipulated timeline,” the company said.

In October 2023, almost two years ago, the same facility was issued a Form 483 with nine observations by the U.S. FDA on completion of a product specific PAI. In a filing on Saturday, Dr. Reddy’s said the latest development is pursuant to the earlier inspection.