It’s strike three for India’s Wockhardt, which has had a third plant in its home country banned from exporting to the U.S.
The FDA on Friday added Wockhardt’s bulk manufacturing plant in Ankleshwar, India, to its import alert list, joining plants in Waluj and Chikalthana that the FDA banned in 2013. The alert does not say why the plant’s products were banned but Wockhardt has a history of manufacturing shortcomings at other plants.
The agency followed the earlier bans up with a warning letter that criticized the drugmaker for hiding failed testing results and manipulating tests to make it appear that drug batches had met FDA standards when they hadn’t. The FDA said Wockhardt employees at the Waluj plant had tried to destroy records and lied to inspectors about having giving them access to all drug manufacturing areas.
Wockhardt Chairman Habil Khorakiwala last year told investors the company hoped to get those two plants again approved for U.S. exports in 2016. The remarks came a day after the Indian drugmaker reported that sales in the U.S. last fiscal year were off by 50%. In its latest annual report, Wockhardt reported that total revenues for the company were off about 6% to $674 million but didn’t break out its U.S. sales.
In the annual report, Wockhardt noted that the FDA had observations after inspection of four of its plants, including the Ankleshwar facility, as well as its plants in Chikalthana and Waluj, where it said remediation efforts were still under way.
The fourth plant was a new sterile injectables facility in Shendra that Wockhardt saw as its best shot at restoring a U.S. business devastated by the FDA product bans. But the company earlier this year said the FDA found issues during an inspection to determine if it was ready for U.S. approval.
by Eric Palmer | Aug 8, 2016