FDA picks apart processes at Jubilant HollisterStier plant

Warning Letter notes lots that failed some tests released anyway
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Jubilant HollisterStier picked up some work recently when the maker of imaging agents needed to move production away from the beleaguered Ben Venue plant in Bedford, OH. Turns out Jubilant HollisterStier is having some issues of its own at a plant in Canada.

In a Warning Letter just posted to its website, the FDA says the contract manufacturer released lots from its plant in Kirkland, Québec, where it manufactures sterile injectable products, even after some of the batches were 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."

Further, the Warning Letter says the facility was not investigating every rejected batch as the FDA requires and so didn't implement some kind of preventive actions to keep the problems from recurring. The agency was unimpressed with the company's response that the "process is known to generate occasional out of limit in-process … aggregate particle density results." Why didn't the company get to the root cause and fix it? The FDA wants to know.

An investigator was also troubled by the fact that the plant was not putting in place "corrective and preventive actions (CAPAs) in a timely manner." Some CAPAs were unresolved for 500 to 700 days. One was more than two years old, the Warning Letter says. The inspector was also put off by the fact that he observed 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. The FDA said Jubilant's four letters in response to the March 2012 inspection still weren't hitting all of its concerns and to top it all off, it said the company hadn't even bothered to register the plant as required. 

FDA Commissioner Margaret Hamburg in a speech recently urged companies to put out a greater effort to hit quality standards, noting that failures lead not only to costs for manufacturers but shortages for patients. The agency is also expanding inspections of manufacturing plants boosted by user fees now being kicked in by API and generic drugmakers, but the sequestration law is limiting the FDA's access to those fees and so the extent to which the agency can expand. 

- here's the Warning Letter

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