FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Danish API Maker Cited for Sterility Violations

Sept. 19, 2018

The FDA slapped Xellia Pharmaceuticals with a Form 483 after finding quality and sterility shortcomings during a May inspection of its Copenhagen facility.

The manufacturer of antibacterial and antifungal treatments had inadequate procedures for data reviews performed by quality control chemists for HPLC systems used to assess product purity and potency. Specifically, system test reports failed to show whether manual changes to integration parameters were acceptable and whether it investigated questionable data.

The company’s periodic review of its electronic analytical systems — part of the quality assurance team’s internal audit — lacked a review of project folders for unreported data or assurance that quality control chemists reviewed original raw data and transferred the result summaries appropriately.

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