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.

CAPA continues to be the top reason for Form 483s and warning letters. To ensure your firm isn’t caught in the FDA’s crosshairs, purchase the industry’s most authoritative guide on building and implementing an effective CAPA compliance program, Managing Effective CAPA Systems.