Houston Specification Developer Written Up for Complaint Handling

The FDA hit Medical Accessories and Cables in Houston, Texas, with a Form 483 for lax handling of complaints.

An inspection of the specification developer of monitoring system cables, fetal transducer cables and other products found complaints related to device, labeling or packaging specification failures that were not investigated.

For example, a complaint about cables that were not recognized by the customer’s monitor was dealt with by replacing the cables, not by an evaluation and investigation, the agency said.