Mumbai-based drugmaker Wockhardt is once again in the crosshairs of the U.S. Food and Drug Administration (FDA) after the American regulator found the pharma giant was hiding the results from failed tests on drugs and deleting the resulting data from computer systems at a plant in western India, according to a report by Reuters.
Reuters filed a Freedom of Information request to see the report sent to the company by the FDA.
Wockhardt is a key player in India's $15 billion generics industry, which is a major exporter to the United States and Europe. But sales have been hit as regulators in both areas have banned several Indian companies from exporting certain drugs because of falsified test results and quality-control lapses at manufacturing plants around the country.
Reuters reported that Wockhardt makes about a fifth of its $670 million in annual revenues from sales to the U.S. and that the FDA was targeting its Shendra plant in western India. That plant makes injectable medicines, which analysts say are key to Wockhardt's U.S. plans, according to Reuters.Wockhardt Chairman Habil Khorakiwala
Wockhardt did not comment to Reuters on the FDA action and did not reply to emails sent by FiercePharmaAsia.
Wockhardt's plant fell victim to the dreaded Form 483 reports that are filed by the FDA when it believes that conditions at plants could lead to subpar drugs that could harm humans.
The Jan. 12 report, Reuters said, showed that the results of 22 failed tests had not been recorded and data files were wiped from some machines. The FDA report did not comment on specific drugs involved and did not say whether the violations could cause the drugs to be unfit for human consumption.
The FDA also said some pharmaceutical ingredients were not properly stored or labeled and a "rejected drug batch was stored in the 'approved material' area, and some batches did not carry expiry dates," the report said.
Wockhardt is barred from shipping any drugs made at the plant to the U.S. until it receives FDA approval. Two other plants of the company's 8 total in India are also banned from exporting to the U.S. because of quality-control problems.
- here's the report from Reuters