Wockhardt is now in the FDA's doghouse over vet drugs from 2 plants

The FDA is no more satisfied with the way India's Wockhardt manufactures veterinary drugs than with the way it makes human drugs. In a recent notice, the agency put import alerts on the drugmaker's plants in Chikalthana and Waluj that are already banned from shipping human drugs to the U.S. The problems with its vet side of things have not been delineated publicly, but FDA warning letters have laid on for problems in its production of human drugs. Among many other issues cited, the agency said quality assurance personnel tried to hide records of batch failures and tried to destroy a test sample an inspector asked to see during an inspection. Computers were not secure and there was also standing urine in the drain of a bathroom near a sterile manufacturing area. Story | More

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