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Jubilant: FDA Warning to Montreal Plant Is Resolved

March 7, 2014

The FDA has lifted a February 2013 warning letter issued to Jubilant HollisterStier’s manufacturing facility located near Montreal, Canada, facility and deemed it acceptable after a follow-up inspection in September 2013.

The February 2013 warning letter to the company, a contract manufacturer owned by India’s Jubilant Life Sciences, did not restrict manufacturing and/or affect business, however, the FDA was not approving new products.

Jubilant has since strengthened the quality oversight on the production floor, are performing a close follow-up on open investigations and CAPA and have implemented the AQL inspection after the 100% manual inspection of injectable products.

The agency last year handed a warning letter to Jubilant HollisterStier’s Montreal-area, Québec, facility claiming the company’s investigations into failures of injectable drugs to meet certain in-process requirements are not always performed. — Lena Freund

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