Days, after the US Food and Drug Administration(US FDA) slapped a Form 483 against the Indian drug major Dr Reddy's Laboratories after completing the inspection of its Duvvada facility in Vishakhapatnam, the pharma major was dealt a second blow as German regulatory authorities made six major audit observations for the same plant.
"On September 7, the Regulatory Authority of Germany (Regierung von Oberbayern), concluded an audit of our formulations manufacturing facility in Duvvada, Vishakhapatnam with zero critical and six major observations. Products manufactured at the facility are not currently exported to the European Union. The company will be