Ranbaxy et la FDA se mettent d'accord sur un "Consent Decree"
Cet accord met ainsi fin à plusieurs mises en demeure de l'agence américaine sur des insuffisances répétées en matière de "data integrity" et de "compliance".
Par exemple, sur un site indien en 2006 :
"1. Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific drug product and lot tested [21 CFR 211.194(a)(4)].
Review of stability data by our investigative team disclosed that prior to November 2004, your firm did not maintain documentation of [redacted] operating conditions and settings used for [redacted] analysis nor the complete raw data. After November 2004, the operating parameters were maintained with the relevant [redacted]. However, the[redacted] electronic raw data was not saved. According to the Director of Quality Assurance, Ranbaxy began saving[redacted] electronic raw data just recently at the beginning of February 2006. However, that was not observed during the inspection."
Dans un courrier de 2009, le Dr. Janet Woodcock reproche à Ranbaxy d'avoir fourni des enregistrements erronés dans des dossiers d'enregistrements à la FDA : "The Center for Drug Evaluation and Research has determined that Ranbaxy Laboratories Limited (Ranbaxy) submitted untrue statements of material fact in abbreviated and new drug applications filed with the Agency."
Ranbaxy a annoncé la provision de 500 M$ pour couvrir sa responsabilité civile et pénale découlant d'actions potentielles menées par le département américain de la Justice.
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