It is one down and one to go for Indian drugmaker Jubilant Life Sciences when it comes to satisfying the FDA over the operations of its North American manufacturing facilities. The company says the FDA has given it a clean bill of health on a facility in Montreal, Canada, that was issued a warning letter in February 2013. The drugmaker has another facility in Spokane, WA, where the FDA still has concerns.
The FDA has yet to publicly post a close-out letter indicating its satisfaction, but the company felt comfortable enough to issue a statement Friday that all is well with the Canadian plant where it makes sterile injectable drugs. It says: "Jubilant Life Sciences has received a communication from the US Food and Drug Administration (FDA), classifying its pharmaceutical manufacturing facility at Montreal, Canada, as 'Acceptable.' This resolves all issues raised by the FDA on the facility in February 2013 and subsequent communications."
Among the problems the FDA cited in its 2012 visit to the Montreal plant was the fact that it released drug batches that had failed to meet 100% of its visual inspections and that it didn't get to the root cause of why batches failed. An inspector was also concerned about water running on the floor of the equipment washroom that was tracked into the pharmaceutical corridor leading to the sterile production hallway, a production line, and the vial-filling area. But Friday the drugmaker said that the FDA signed off on the plant after a re-inspection in September.
The statement made no reference to Jubilant's Spokane facility, which received a warning letter in November. Among other problems, the FDA noted in that inspection that the plant had not put together a written plan, with Quality Control oversight, of how sterile manufacturing might be affected by a major remodeling that included replacing windows, resurfacing the floors and painting ceilings. The inspectors also noted it had not gotten to the root cause of unexplained increased levels of some impurities which led Jubilant to recall some products.
Still, Jubilant getting the Montreal plant back on track with the FDA is a piece of good news for the Indian drug industry, which has had its fair share of problems as of late. Since May of last year, the FDA has banned two Ranbaxy Laboratories plants and two Wockhardt plants from exporting to the U.S. Their problems were repeatedly hashed over in world media reports during a recent trip by FDA Commissioner Margaret Hamburg to India, where quality manufacturing was at the top of of her discussion list.
- here's the release
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