FDA Discovers Wockhardt Hid Failed Tests and Deleted Data at Indian Plant
January 29, 2016
By Mark Terry, BioSpace.com Breaking News Staff
The U.S. Food and Drug Administration (FDA) sent a report to Mumbai, India-based Wockhardt , indicating that the company intentionally hid and deleted data regarding failed tests at its Shendra facility.
Wockhardt has manufacturing facilities in the U.S., UK, Ireland and France, as well as India. The company reports about $670 million in annual revenues, of about which 20 percent comes from the U.S.
The FDA filed a Form 483 on Jan. 12, which Reuters acquired through a Freedom of Information Act request. In addition to other violations, the FDA’s audit indicated that the data from 22 failed tests had not been recorded, and multiple files had been deleted from some of the company’s databases.
The report also found that some pharmaceutical ingredients were not stored or labeled appropriately. Until the FDA is satisfied that the company has fixed these issues, the company is currently banned from exporting products to the U.S. from two of the company’s eight India plants. The company has previously had problems with the FDA regarding its Waluj and Chikhalthana plants.
On Monday, Jan. 18, Wockhardt’s chairman, Habil Khorakiwala, stated that it planned to comply with all of the FDA’s citations for its Shendra unit in two months.
“The FDA has made nine observations about the Shendra plant, but we believe none of them are critical,” said Khorikiwala in a conference call with journalists, as reported by the Business Standard. “By the time we respond to the FDA in 15 days, we would have complied with half of these and we expect to comply with the balance in two months.” He also denied that there were data integrity issues.
The company has filed for permission to market 15 products in the U.S. from third-party sites. It also markets drugs in the U.S. through its facility in Chicago.
In 2015, after the reports about the Waluj and Chikhalthana units, the company’s sales dropped by 50 percent in the U.S. After the Shendra plant reports broke, stock prices dropped almost 15 percent.
Wockhardt traded for 1,992.80 INR (Indian Rupees; $29.89 US) on April 7, 2015, dropped to 1,234.70 INR ($18.52 US) on April 28, rose back to 1,722 INR ($25.83 US) on Aug. 19, then back down to 1,176.25 INR ($17.64) on Sept. 7. Shares traded for 1,627 INR ($9.41) on Jan. 12, 2016 and are currently trading for 1,276 INR ($19.14 US). The current exchange rate is 1 INR is equal to 0.015 U.S. dollars.
Analysis of the form, according to India Economic Times, finds that there were no issues with procedures, but focused more on some data issues. Also, it found, some rejected materials were not disposed of properly. “These issues can be solved in a very short time and are not major issues,” the reporter said in the video report, reporting on the Shendra facility.