FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

FDA Hits Dynaflex on CAPA, Device History Records

Aug. 2, 2018
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The agency issued the 483 following an April inspection of the company’s St. Ann, Missouri facility.

Investigators found the company’s CAPA procedures did not include an analysis of quality data to identify the causes of nonconformances and that the firm failed to validate corrective and preventive actions.

The facility also lacked design controls for its class 2 medical devices, including design history files, design inputs or outputs, verifications, transfers or design changes.

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