California Devicemaker Cited for Complaint Handling

May 7, 2019

A Santa Cruz, California device manufacturer was hit with a Form 483 over failure to create complaint reports for multiple supplier corrective action requests (SCARs).

During a Dec. 3-21, 2018 inspection of Duke Empirical, the agency discovered 14 SCARs, but the devicemaker failed to explain why it didn’t create the required complaint reports.

In one case, the customer said the device leaked air during aspiration; in another, a physician claimed the device’s cannula balloon failed to inflate during a medical procedure.

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