The FDA issued a Form 483 listing possible violations of the Food Drug and Cosmetic Act after inspecting Wochardt’s drugmaking facility in Morton Grove, Illinois, over seventeen days between January and March, according to a document on the agency’s website.
Two of the Mumbai-based drugmaker’s Indian facilities are already banned from exporting to the U.S. after inspections where the FDA reported similar violations. If Wockhardt fails to address the problems, the latest observations could hurt the company’s supply to its biggest market.
The facility generated more than half of Wockhardt’s U.S. sales last quarter. Wockhardt’s U.S. business dropped 26 percent in the year ended March 2014 following the import restriction on the two other factories. The contribution from U.S. sales dropped to 45 percent of total revenue from 51 percent the year before.
The Form 483, issued on March 26 and containing 12 observations, said the plant’s quality unit doesn’t have documented procedures and some systems weren’t followed.
The Wockhardt factory in Illinois is the latest Indian facility to come under FDA scrutiny. Four factories from India’s Ranbaxy Laboratories Ltd. are banned from selling to the U.S. and the FDA this year put import restrictions on a Sun Pharmaceutical Industries Ltd. plant.
The document cited the specific practice of performing trial product tests and said the company hasn’t established appropriate procedures designed to “assure that products conform to appropriate standards of identity, strength, quality and purity.”
Similar product testing irregularities were also cited in two warning letters issued to Wockhardt’s banned facilities at Chikalthana and Waluj in Aurangabad, India, the document said, leading the agency to believe that the company’s quality unit is not fully monitoring systems at its plants.
The FDA also cited raw testing data files that could be accessed and deleted by anybody, and workers untrained in current good manufacturing practices.
“It is difficult to say what kind of a position FDA will take,” said Managing Director Murtaza Khorakiwala on a May 27 call with analysts, referring to the latest inspection. “But I believe that according to us, the inspection was not -- I mean, was not a very negative inspection.” Dominic D’Souza, a spokesman for Wockhardt in Mumbai, declined to comment today on the FDA document.
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