German regulators have signed off on a corrective and preventive action plan (CAPA) for one of Dr. Reddy’s formulation production facilities in India, allowing the company to market drugs manufactured at the site for the European Union.
News of the acceptance of the CAPA by German regulators for the Duvvada, Vishakhapatnam facility was given in a notification (PDF) by Dr. Reddy’s to the Bombay Stock Exchange. In the letter, the company said the plant will be re-inspected by the end of 2018.
In September, the Central Authority for Supervision of Medicinal Products in Bavaria suspended the manufacturing authorization for the site. The suspension came in the wake of an inspection that uncovered six major violations that included problems with the plant’s protocol, review and reporting systems that were designed to systematically skirt reporting "discrepancies, nonconformances, incidents and unusual events.”
In August, German regulators cited a Dr. Reddy’s plant in Bachupally, India, that had already run into issues with the FDA.
The U.S. regulatory agency has put Dr. Reddy’s under intense scrutiny. Last spring, the Indian drugmaker said an inspection by the FDA of a formulations plant in Bachupally in Hyderabad resulted in a Form 483 with 11 observations. It was not the same plant that German regulators cited.