FDA warns Wockhardt, Fosun

Abstract

The U.S. FDA has again warned the Indian generic drug producer Wockhardt about problems at one of its facilities, this time in the U.S. The agency also warned a subsidiary of Fosun Pharmaceutical—one of China’s leading drug producers—regarding a facility in southwest China. In a statement to the National Stock Exchange of India, Wockhardt says FDA has banned its Chicago-based unit, Morton Grove Pharmaceuticals, which produces oral and topical formulations, from launching new products in the U.S. until it addresses manufacturing deficiencies. In December, FDA warned Wockhardt about failure to maintain sterile conditions and manufacturing data integrity at a facility in Gujarat, India. In China, FDA uncovered data integrity issues at Fosun’s Chongqing Pharma Research Institute subsidiary, which produces active pharmaceutical ingredients. Investigators found that the firm deleted “entire chromatographic sequences” and other data from its computer records.