Indian drugmaker Wockhardt hid the results of failed tests and deleted data from its systems at a plant in western India, according to a report by the U.S. Food and Drug Administration sent to the company earlier this month and seen by Reuters.
Issues around “data integrity”, maintaining accurate and consistent databases, are key to the U.S. watchdog, which regulates the world’s largest market for generics producers.
Wockhardt is the latest of several major players in the $15 billion Indian drugs industry to be hit by U.S. regulatory action over the past few months.
It makes around a fifth of its $670 million in annual revenues from the United States and had said the Shendra plant, the site that prompted the FDA report, would boost its U.S. business. Shendra makes lucrative injectable medicines, which analysts say are key to Wockhardt’s U.S. plans.
Wockhardt did not return several telephone calls and emails requesting comment on the detailed report.
The FDA did not immediately respond to a request for comment on its report. It issues such reports, known as a ‘Form 483’, when its staff believe that conditions at a manufacturing site could lead to products that are harmful to human health.
In the report, dated Jan. 12, the FDA said that among other violations, the audit showed that the results of 22 failed tests had not been recorded. It also found multiple data files had been deleted from some machines.
The FDA did not detail whether the files or tests related to specific drugs, or whether the violations could impact the quality of medication produced at a plant which still exports to Britain and Ireland.
FDA inspectors also reported finding pharmaceutical ingredients that were not stored or labeled properly. A rejected drug batch was stored in the “approved material” area, and some batches did not carry expiry dates, the report said.
Wockhardt will now need to tell the FDA how it plans to fix the problems underlined in the report. It cannot ship any products from the plant to the United States until the FDA is satisfied, a blow for its recovery plans.
Wockhardt told investors earlier this month that it had been issued a notice from the FDA about manufacturing violations at the Shendra plant. But Chairman Habil Khorakiwala told reporters he believed none of the FDA’s observations concerned the integrity of the company’s data.
He said then that all the issues raised would be resolved within two months.
Two of the company’s eight plants in India are separately banned by the FDA from exporting to the United States, the world’s biggest market for generics, over quality concerns.
Reuters obtained a copy of the FDA report through the Freedom of Information Act, which allows the public to ask for the disclosure of unreleased information.