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Medical Devices / Inspections and Audits

FDA Hits Illinois Devicemaker for CAPA Failures

Oct. 1, 2018

The FDA observed deficiencies in corrective  and preventive action (CAPA) procedures during an inspection earlier this year of the Richard Wolf Medical Instruments facility in Vernon Hills, Illinois.

The agency inspectors found that the Richard Wolf Medical Instruments facility did not properly identify corrective actions for non-conforming products and the facility did not adequately document corrective actions, root causes and effectiveness checks.

The agency also faulted the devicemaker for its complaint procedures, noting that its form for documenting complaint activities did not include a date and signature of the performer or a verifier for the investigation.

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