Indian generic drug manufacturer Wockhardt has been asked by America's Federal Drug Administration to conduct a global assessment of its plants to ensure that the drug produced by the company conform to FDA requirements for safety, efficacy, and quality.
Questioning the reliability and accuracy of tests conducted by Wockhardt, the FDA in a letter expressed concerned about its inability to implement a robust and sustainable quality system.
"It is apparent that Wockhardt is not implementing global and sustainable corrective actions. It is essential that your firm implement a robust quality system," the FDA said in a letter dated November 25.
The FDA reminded the Indian company that it is responsible for ensuring that the firm's drug manufacturing operations comply with applicable requirements and produce acceptable quality drugs.
"FDA strongly recommends that Wockhardt's executive management immediately undertake a comprehensive and global assessment of your manufacturing operations to ensure that your systems and processes, and ultimately, the drug products you manufacture, conform to FDA requirements for safety, efficacy, and quality," the letter said.
Of late, the FDA has targeted the largest Indian drug manufacturing producers including Ranbaxy. The FDA Commissioner Margaret Hamburg is slated to travel to India soon.