Dr. Reddy’s Laboratories Slapped With 483 After FDA Preapproval Inspection
July 18th, 2022 // 8:23 pm @ jmpickett
Dr. Reddy’s Laboratories has been hit with another 483 for problems with its production facilities.
FDA performed a preapproval inspection at the firm’s formulations manufacturing plant which is known as FTO 11. Dr. Reddy’s told the press that the agency gave them a two-item 483 that focused on subpar manufacturing standards. The FDA inspection took place in June and July 2022.
Dr. Reddy’s didn’t provide additional details yet about what the 483 was for, but the plant is in Srikakulam, India.
The company also received a 483 in 2019 when it got an eight-item 483 at its oncology drug facility in India. However, the firm said in 2020 that the concerns in the 483 were voluntary action indicated. That means the facility met minimum safety and compliance standards.
Other Indian drug plants also have been in FDA’s crosshairs lately. Lupin’s API plant in Tarapur also got a 483 in April 2022. This 483 involved poor manufacturing processes and improper cleaning protocols.
