India's Wockhardt, whose issues with the FDA and regulators in Europe just keep piling up, has been hit with two more import alerts. This time, the bans are for the veterinary drugs made at the same two plants the FDA banned from shipping human drugs.
The agency issued alerts last week for Wockhardt's plant in Chikalthana and for its plant in Waluj. The alerts give no details, but the FDA has lined out problems it found on the human side of manufacturing in a recent warning letter covering the two facilities.
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. 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 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.
- here's the FDA notice