Dr. Reddy’s Laboratories formulations manufacturing facility in Srikakulam, Andhra Pradesh, has obtained an institution inspection report (EIR) from the U.S. Meals and Drug Administration (U.S. FDA)
“We want to inform you that the corporate has obtained EIR… the company concluded that the inspection is closed,” the Hyderabad-based drugmaker knowledgeable the inventory exchanges on Thursday.
Final month, Dr. Reddy’s had intimated the exchanges about U.S. FDA issuing a Kind 483 with two observations following completion of a pre-approval inspection of the formulations manufacturing facility (FTO 11) from June 30-July 7. The corporate had then mentioned it will tackle the problems raised in observations, inside the stipulated timeline.
Via Kind 483, the U.S. FDA notifies the corporate whose facility is inspected of objectionable circumstances noticed by its officers that will represent violations of the Meals Drug and Beauty Act and associated Acts.
By- The Hindu