Dr. Reddy’s unit gets EIR from U.S. FDA
Dr. Reddy’s Laboratories formulations manufacturing facility in Srikakulam, Andhra Pradesh, has received an establishment inspection report (EIR) from the U.S. Food and Drug Administration (U.S. FDA)
“We wish to inform you that the company has received EIR… the agency concluded that the inspection is closed,” the Hyderabad-based drugmaker informed the stock exchanges on Thursday.
Last month, Dr. Reddy’s had intimated the exchanges about U.S. FDA issuing a Form 483 with two observations following completion of a pre-approval inspection of the formulations manufacturing facility (FTO 11) from June 30-July 7. The company had then said it would address the issues raised in observations, within the stipulated timeline.
Through Form 483, the U.S. FDA notifies the company whose facility is inspected of objectionable conditions observed by its officials that may constitute violations of the Food Drug and Cosmetic Act and related Acts.