FDA warning letter lays out issues at banned Wockhardt plants

India is a key production hub for generic drugs that come into the U.S., but the problems for some of its top drugmakers just don't seem to end. This month, the FDA hammered a second Wockhardt plant in India, banning most of the products the generics drugmaker could ship to the U.S. A warning letter posted today shows that the plant was up to some of the same tricks that led the agency to its first ban earlier this year.

The warning letter says the Wockhardt plant in Chikalthana was testing "trial samples" of some drugs, then linking results from those to official samples that had not met test requirements. "Therefore, it appears that the batch (b)(4) did not pass the 'trial' analysis but met specifications when the 'official' sample was tested shortly thereafter," the agency noted. Further, inspectors found that some results were not being kept on hard drives where they could confirm the results. And because the drugmaker does not limit computers to specific employees, there is the chance that test results that don't live up to standards could be deleted or changed. The FDA noted similar issues at Wockhardt's plant in Waluj, a facility the FDA issued a ban against in May.

The problems for the Indian drugmaker just keep piling up. The U.K. has also banned most of the drugs coming out of Wockhardt's plant in Chikalthana. The facility generated $230 million in U.S. sales in Wockhardt's last fiscal year. The U.S. has been the company's largest market and accounted for about 43% of its revenues. Wockhardt has already said the ban at its Waluj plant could cost it $100 million in lost revenues.

Wockhardt, of course, is not the only Indian drugmaker to face import bans. In September, the FDA imposed the ban on Ranbaxy Laboratories' plant in Mohali, India, after inspectors found rampant problems. The drugmaker's other two Indian plants that had sold into the U.S. were put on import alerts in 2008. In May, Ranbaxy agreed to pay the U.S. $500 million to settle for problems uncovered at those facilities, but they remain unable to supply the U.S. With the Mohali ban, Ranbaxy's New Jersey plant is its only one approved for sales in the U.S., a market that had provided 40% of its revenues. Both drugmakers have acknowledged that the problems are already eating away at their revenues.

The FDA has been beefing up its staff in India to try to get on top of problems there. FDA Commissioner Margaret Hamburg is slated to travel to India this year or early next year for the first time in her tenure in that role. The agency has been marshaling resources there, adding inspectors and a new head of the FDA office, Altaf Ahmed Lal, an Indian-born Ph.D. Lal has said that working with manufacturers there on quality issues is one of his top priorities.

- here's the warning letter

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