UPDATED: Wockhardt FDA warning letter says QA staff tried to mislead inspectors

By Tracy Staton and Eric Palmer

Bad news about Wockhardt's manufacturing quality keeps getting delivered to the Indian generic drugmaker. In May, the company said its plant in Waluj, India, had been placed on an import ban by the FDA, and shortly after, regulators in the U.K. took the same action. The U.K. even recalled 16 products. Now the FDA warning letter that outlines the agency's concerns has arrived and it does not paint a pretty picture of the problems at the plant.

The extensive letter brought to light a number of issues, including vials that were unmarked and the lack of washing and toilet facilites for employees. But two of the top observations from the FDA said inspectors were kept out of an aseptic filling area they should have been allowed to inspect, and that it appeared Wockhardt employees misled inspectors, employees having thrown away some "raw data" reports. The warning letter said an inspector found about 20 "torn raw data records in the waste area." The inspector was assured by a quality assurance office that these were all of the discarded reports in that waste area, but they later found that more had been put in another area. The reports included such things as microbial testing data and stability reports.

In a notification to stock exchanges Saturday, the drugmaker said it has now received a warning letter from the FDA, related to the agency's import alert announced two months ago. 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 them. 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.

- here's the warning letter
- see the MoneyControl story

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