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Home » Design Change, Validation Found Lacking at InterX Technologies

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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