FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

Capsugel Loses GMP Certificate for Bend Research

May 23, 2016

Swedish authorities withdrew the EU-GMP certificate for Capsugel’s Bend Research for repeated GMP violations, including data integrity issues.

The country’s Medical Products Agency said the action was necessary after a Feb. 24 inspection turned up 21 violations at the company’s plant in Bend, Ore., two of them critical and seven deemed major.

The two critical violations and one major violation involved data integrity issues, Swedish authorities said, while other concerns were raised over process validation, hygiene routines, documentation routines and other issues.


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