Easyscan Cited for CAPA, Complaint Handling Deficiencies
The FDA issued a Form 483 to Easyscan for deficiencies in its complaint-handling and CAPA procedures.
The agency issued the form following a May-June 2017 inspection of Easyscan’s facility in The Hague, Netherlands.
Investigators found the firm’s complaint-handling procedures did not adequately ensure complaints were processed in a timely manner or evaluated for MDR reportability. The procedures, investigators wrote, did not include adequate requirements to “ensure that when a decision is made not to investigate a complaint that the reason is documented and the individual making the determination to not investigate is recorded.”
None of the complaints investigators reviewed included sufficient documentation of the MDR evaluation identifying whether the device was being used for a patient at the time of the failure or whether it was being used for diagnosis. Not all of the complaints were properly dated or included the results of the subsequent investigation, nor did all of them include any reply to the complainant.
Investigators also found the firm’s design output procedures did not include adequate requirements for defining output or make reference to acceptance criteria. Procedures for design review did not feature adequate requirements to ensure participants at each review properly represented all functions in the design stage.
The FDA also cited the company for its CAPA procedures, finding it did not verify or validate all corrective and preventive actions to ensure they did not adversely affect the devices or include requirements to document all activities. Two of three CAPA files reviewed did not fully document all activities including verification and validation.
The company also lacked acceptable rework instructions for nonconforming devices and did not require retesting and re-evaluation of nonconforming products after reworking, including a full determination of any adverse effects.