The Quality Lowdown: Spanish Falsification, Czech Mold And Dutch Contamination Cited After EU Lull Ends

Barcelona’s Union Quimico, Czech Republic’s Vakos and The Netherlands’ Pharma Essentials among those cited as the EMA ramps up in Amsterdam.

The Quality Lowdown

A Spanish maker of active pharmaceutical ingredients was slammed for obstructing inspectors and falsifying data, while Czech and Italian firms were chastised for lack of sterility assurance as European pharmaceutical inspectorates emerged from the European Medicines Agency’s Brexit-move-related hiatus with vigor, judging from EU GMP noncompliance statements published over the past month.

With the formerly London-based agency now ensconced in Amsterdam, new noncompliance notices have been appearing routinely again at its EudraGMDP...

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