Vasomedical 483 Details Complaint, CAPA Issues

Vasomedical received a four-observation Form 483 due to shortcomings in complaint reviews and other GMP slips.

The Westbury, N.Y., company did not automatically consider service repairs and product returns as complaints and process them according to requirements, the forms says. Vasomedical also did not consistently issue corrective action requests to evaluate complaints for possible device, labeling or packaging failures.

Further, Vasomedical's complaint handling procedure did not specify that, when there is no investigation, the company must keep a record explaining the decision and include the name of the employee responsible for the decision.

The form detailed CAPA problems as well. Vasomedical's CAPA procedure did not require it to implement and record changes to methods and procedures that are made to correct and prevent quality problems.

Meanwhile, the company opened a corrective action report after a customer complaint about the noise level of the TS4 system during treatment. The firm initiated a corrective action, but did not document any verification or validation.

The final observation notes discrepancies in device history records for the Lumenair EECP Therapy System. For example, a final acceptance test record did not state the identity of the person who performed final acceptance testing procedures. There was also no documentation of whether the system passed the quality control test or not. The device was released by quality control.

Vasomedical did not provide a comment on the form. The Form 483 is available at www.fdanews.com/12-22-14-Vasomedical.pdf.