FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Spanish Regulator Cites Drugmaker for Quality Fraud

July 23, 2019
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Spain’s drug regulator called out Barcelona drugmaker Novocat Farma for serious quality failures that included forged signatures.

An inspection in June revealed the technical director’s signature was forged on various documents while she was on sick leave.

The firm had stopped recording deviations and out-of-specification results for various drug products since January, according to an inspection report filed in the EU’s EudraGMDP inspection database.

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