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FDA Knocks German Devicemaker for CAPA Problems

September 11, 2019

The FDA slapped a device manufacturer in Baden-Württemberg, Germany with a Form 483 over how it handled corrective and preventive actions.

HGR Instrumente closed its CAPAs once it implemented the corrective actions, failing to verify them for effectiveness and document the results, the agency said following an inspection.

The firm also failed to document why it did not launch CAPAs for certain customer complaints, a requirement of its complaint handling procedure.

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