FDA handed devicemaker Synovis a Form 483 for not initiating corrective and preventive actions for nonconformities to its Terminally Sterilized Vascu-Guard patch.
The firm did not follow its complaint handling SOP following complaints from 26 companies that users were unable to determine the rough side from the smooth side of the patch used in vascular surgery.
Moreover, the FDA notes that in the firm’s instructions for use for physicians, it says that if the rough side is implanted toward the vascular surface, it could “cause permanent impairment or life threatening injury, which is a critical failure,” the 483 says.
The firm addressed complaints through a Frequently Asked Questions document circulated by sales reps, and it initiated risk assessment activities internally following complaints, but it did not do so within the CAPA system, the 483 notes.
Also, the firm did not evaluate and investigate the failure of the device to meet its specifications nor did it evaluate and escalate investigations when the complaint rate exceeded the expected occurrence rate, the FDA says.
Finally, the 483 cites the firm for design validation deficiencies for not ensuring the device conforms to defined user needs.
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