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Biotech / Medical : Regeneron Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (1982)	12/8/2016 12:57:10 PM
From: Miljenko Zuanic	Respond to of 3559

France authority last inspection of Le Trait, France facility was on 11-7-2014, and GMP certificate for sterile (liquid formulation) injectable biologic was issued on 3-2015 (valid for at least 3 years). No EMA citation for this facility. http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do?ctrl=searchGMPCResultControlList&action=Drilldown&param=31646 So, it is not clear what is FDA citation problems that L-analyst refer? FACT that FDA DID NOT block production of other sterile biologic products at facility further complicate correct assessment of the problems.