Elite Medical Supply Cited for Design Control Procedures, CAPAs

The FDA cited Elite Medical Supply of New York for problems with its design control procedures and handling of CAPAs and complaints.

Investigators issued the Form 483 after a December 2017 inspection of the device specification developer’s West Seneca, New York facility. They found the design for the company’s Elite Medical Multi-Mode Stimulator was bought from another company but that Elite Medical did not document a review or approval of the design history file to ensure completeness and accuracy.

Investigators also found that procedures for design validation did not include any requirement to demonstrate equivalency to the production units.