India's Jubilant Life Sciences has received a second warning letter this year for its operations in North America. This time, the company landed in hot water for problems at its Jubilant HollisterStier sterile manufacturing plant in Spokane, WA. The citation comes 10 months after the FDA criticized operations at its facility in Kirkland, Québec.
According to the warning letter posted the the FDA website, the FDA criticized the plant for not having appropriate written procedures to prevent microbiological contamination of sterile drugs or products purporting to be sterile and wasn't satisfied with its system for cleaning and disinfecting aseptic processing areas and equipment. The letter points out that the company recall some lots when it found unexplained increased levels of impurities and had to reduce the expiry of the product, but hadn't gotten to the root of the problem.
In a statement, The Economic Times reports, Jubilant offered this assessment: "We expect that the on-going manufacturing, distribution and sale of products from this facility will not be impacted as the WL will affect new approvals only." It said it is taking steps to solve the problems. According to Reuters, sales of drugs from the facility accounted for 7% of the drugmaker's revenues in the 6 months ended in September.
The website for the 191,000-square-foot facility says it specializes in parenteral contract manufacturing and sterile contract manufacturing. Jubilant also does sterile manufacturing at the plant in Québec that was cited earlier by the FDA. That warning said Jubilant released lots even after some of the batches were found to be out of spec. The inspector was told during the March 2012 inspection that the company "only inspects lots once regardless of the number of defective vial rejection rate." That warning letter also criticized the plant's quality controls because employees were not investigating every rejected batch as the FDA requires and getting to the root of the problems. In August, Jubilant said that it had completed an expansion at the Canadian facility.
The missive for Jubilant's Spokane plant adds to a growing list of actions the FDA has taken against Indian drugmakers. The regulator posted a warning letter last week sent to India's Wockhardt, two of whose Indian plants are now banned from shipping products to the U.S. In September, the FDA took the same action against a Ranbaxy Laboratories plant in India, the third of its facilities there to be prevented from shipping to the U.S. All of the companies claim they are addressing FDA concerns.
Indian companies produce about 40% of the generic drugs sold in the U.S., and the FDA is putting more resources toward overseeing facilities there. The agency has stationed more inspectors there and even named an Indian-born Ph.D. to oversee the operations there.
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