FDA inspectors returned to a Wockhardt plant in Waluj that the agency banned in 2013 and weren't impressed by what they found during the weeklong inspection. New concerns were raised.
Wockhardt CEO Habil Khorakiwala acknowledged the new problems during an in interview with CNBC TV18, Reuters reports. He indicated the new issues were no big deal. "There were no serious observations," Khorakiwala said. "We are dealing with those observations and we would be able to respond and correct all of them in next three-four months."
The initial problems discovered were serious. A warning letter at the time said that quality-assurance personnel tried to hide records of batch failures, started to destroy test samples and told inspectors they had been given access to all areas of manufacturing for the U.S. The inspectors later learned of a cartridge-filling area they were not shown. Inspectors also uncovered "unofficial" records on 75 batches that had a 14% failure rate and problems from black particles to fibers and glass particles in them, while "official records" indicated that the batches all met specifications.
Khorakiwala did not indicate the status of upgrades to a plant in Chikalthana that was also placed on the FDA import alert list in 2013 and where the FDA found similar issues.
The bans have taken a toll on the drugmaker's sales and earnings. In its last financial report, its profits were down 97% to $22 million. It was the second quarter in which its profits were off more than 90%. But Wockhardt is far from the only Indian drugmaker to find itself crosswise with the FDA. The agency has banned plants operated by Ranbaxy Laboratories, Sun Pharma and others.
- read the Reuters story