|Wockhardt Managing Director Murtaza Khorakiwala|
The FDA was not happy that Indian drugmaker Wockhardt has continued to sell in the U.S. products that it had manufactured at two plants before the agency banned them, and said so at a recent follow-up inspection. So the drugmaker will now recall anything left in the U.S. made at those facilities.
Wockhardt made the disclosure today to the Bombay Stock Exchange saying, "As a measure of preparedness and as an abundant precaution, the company has now decided to recall, as a part of remedial measure all the remaining batches in the US market that were manufactured prior to the US FDA Import Alerts even though there is no evidence of risk to patient safety from the products currently available in the US market."
The FDA had banned the plants in Waluj and Chikalthana in 2013 after discovering, among other problems, that employees there had been manipulating data to indicate that batches that had failed testing had instead met specifications, then selling those in the U.S. Inspectors also found that employees were then deleting from some computer indications that batches had not met specifications, also a big problem in the FDA's view.
Just two months ago, Wockhardt had indicated the company was making progress in the FDA's view. In March, the company issued a market filing that the FDA in a follow-up visit to the Chikalthana plant was impressed with its efforts "to bring about a culture change and to build a robust quality management." In that disclosure, Wockhardt said its efforts to secure its computer systems had been "verified" by the agency.
It is key for Wockhardt to get the Indian plants selling in the U.S. again since the bans have devastated its earnings. The drugmaker also has a U.S. plant that is currently contributing about 50% of Wockhardt's U.S. sales, which in turn make up 45% of overall sales for the company. The FDA last year raised concerns about it during an inspection but Wockhardt Managing Director Murtaza Khorakiwala insisted at the time said that the review "was not a very negative inspection" and said the company had responded to the agency's observations.
The drugmaker did have some positive news for the markets today, saying that a potent product facility at Kadaiya, Daman, which the U.K. had banned had won back its EU GMP certification from the Medicines and Healthcare Products Regulatory Agency. But getting to a clean bill of health from the FDA for a plant that has been found lacking can take a long time. Ranbaxy Laboratories, another Indian drugmaker, which was found to be faking drug testing data, has four of its 5 FDA-approved plants cut off from the U.S. market, and two of those have been banned from about 7 years. Ranbaxy was recently sold to Sun Pharmaceutical, which has pledged to do whatever is needed to restore regulators' confidence in the facilities.
- here's the BSE filing