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The QMN Weekly Bulletin

French Regulator Orders Vaccine Manufacturer to Stop Production

May 27, 2016

France’s National Agency for Medicines and Health Products Safety has ordered French vaccine maker Theravectys to halt production at its Villejuif plant for seven months after apparently finding numerous GMP deficiencies.

While the company is permitted to continue storing products at the location, the suspension of Theravectys’ marketing authorization prohibits it from producing any investigational medical products there until Sept. 7. The agency issued the decision Feb. 22, and it was posted to the European database on March 7.

Database records show that an inspection last November unearthed 45 GMP failings, five of which were deemed critical and 17 of which were considered major.

The critical violations run the gamut, with the agency accusing the company of performing media fill tests with unqualified equipment, not having sample areas to test incoming materials, lacking the appropriate measures for gauging particle and microbiological monitoring of clean rooms, failing to have a protocol for determining whether its clean rooms matched federal standards and failing to validate analytic methods and processes for a clinical trial.

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