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USA ⇔ AUT, ESP, FRA, GBR, HRV, ITA, MLT, SWE [GxP / QC / QA]

posted by Helmut Homepage - Vienna, Austria, 2017-11-10 11:19  - Posting: # 17969
Views: 1,180

Dear all,

the EC already confirmed that the FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU.
With November 1st, the FDA confirmed the capability of eight EU Member States (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom). The remaining inspectorates will continue to be assessed until 15 July 2019. See also the EMA’s press release.

Cheers,
Helmut Schütz
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