FDA slams Wockhardt with warning letter on troubled plant

Wockhardt has yet another FDA spanking to report. The Indian drugmaker said over the weekend that the U.S. regulator had issued a warning letter related to shortfalls at its facility in Waluj, India. The plant was already in trouble with the agency and its counterparts across the pond, with drugs made there barred from entry into the U.S., U.K. and EU.

In a notification to stock exchanges Saturday, the Indian company said it has now received a warning letter from the FDA, related to the agency's import alert announced in May. The company said it has already started addressing the problems flagged by the agency at the Waluj plant and that it would take any additional measures necessary to allay the FDA's concerns.

Earlier this month, U.K. regulators banned drugs from the Waluj plant and then recalled 16 of the drugs made there. The ban affected distribution not only in the U.K. but also in the entire European Union, the Medicines and Healthcare Products Regulatory Agency (MHRA) said. The barred products included drugs for high blood pressure, diabetes, epilepsy and depression; though the MHRA said it had no evidence that the drugs were risky to patients and issued the recall as a precaution, the agency said "poor manufacturing standards cannot be allowed to continue."

The U.K. regulator's moves followed the FDA's announcement in May. Wockhardt has said that the U.S. ban alone could cost it $100 million in sales, though the company plans to shift production of some products to other plants in an attempt to soften the blow. In India, the company's shares dropped by 12% as news of the FDA warning letter broke.

- see the MoneyControl story

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