Design Change, Validation Found Lacking at InterX Technologies
The FDA found deficiencies in design change procedures, validation and design verification documentation during a June inspection of InterX Technologies.
The Richardson, Texas-based maker of handheld battery-operated neurostimulation devices for pain management received a five-item Form 483 at the conclusion of the inspection.
The FDA investigator found that a change in the liners was made to the firm’s sterile, cutaneous gel electrodes without adequate documentation. As a result, the firm failed to understand how the release strength of the liner to the gel was characterized, but it still distributed the products to the market. — Tamra Sami