US FDA Flags 7 Issues At Dr. Reddy’s Srikakulam Plant

Dr Reddy's Laboratories Ltd. said the US Food and Drug Administration has issued a Form-483 with seven observations for its formulations facility—FTO 11—in Srikakulam, Andhra Pradesh, following a pre-approval inspection.

The inspection began on July 10 and was completed Friday, the company said in a filing. Dr. Reddy’s added it will respond to the observations within the prescribed timeline.

A Form-483 is issued when an FDA inspection finds conditions that may violate the Food Drug and Cosmetic Act. The pre-approval inspection is conducted to verify whether a facility is capable of producing a drug as described in a company’s application and if its data is reliable. Companies are typically expected to respond within 15 days.