Design Change, Validation Found Lacking at InterX Technologies

September 22, 2016

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

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