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Pharmaceuticals / Inspections and Audits

FDA Calls Out Dutch Manufacturer for Storage Deficiencies

Sept. 20, 2018

The FDA hit Rotterdam, Netherlands-based drugmaker Fagron for inadequate drug product storage and procedures for controlling recalled products at the firm’s Saint Paul, Minn., facility.

The agency found during a Nov. 14-Dec. 21 inspection that the company did not properly control estriol lots it had recalled and instead distributed six quarantined lots to multiple compounding pharmacies.

Fagron told the agency it found multiple root causes behind its failure to control the lots of estriol, including unclear labeling, poor security of the hold bin for recalled materials and a lack of detailed instructions for release. But the agency criticized the firm for failing to determine if more non-conforming drugs were improperly released due to the quality system failure.

The firm said it had developed new procedures to address the issues, but failed to provide documentation showing when they were implemented.

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