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The QMN Weekly Bulletin

Design Change, Validation Found Lacking at InterX Technologies

Oct. 14, 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.

The inspector noted that due to the strong bond of the liner, the gel was pulling away from the carbon layer when the liner was removed.

Validation was also found lacking for the InterX1000 and InterX Personal Sport handheld devices. Standard operating procedures indicated that individuals with clinical expertise would validate the devices, but there was no evidence of expert validation.

Design verification results also were not documented in the firm’s design history file, and conflicting data were observed for a software safety test for the InterX Personal device line, the 483 said.

“Although regression tests indicated all steps passed, I observed variances and/or deviation for certain test steps conducted in the initial test cases prior to regression testing,” the inspector wrote. He also noted that fail results were not accounted for as variances and anomalies in the design verification test summary.

The 483 also pointed to inadequate procedures for design reviews and corrective and preventive actions.

For example, the firm’s standard operating procedures note that for design reviews, at least one reviewer should be present who does not have responsibility for the design. But the FDA inspector observed design review records that documented the design transfer phase of the InterX Personal 1000 device that lacked an employee who was independent of the design stage.

Finally, the FDA cited the firm for failing to establish adequate CAPA procedures. Nine nonconformities were documented in 2014, and four in 2015, but five out of the nine and two of the four were still awaiting disposition at the time of the inspection.

The nonconformance investigations included critical suppliers and involved nonconformities such as brittle plastic caps, contaminated switches, bag mislabeling, missing plates for electrode caps, a missing LED and intermittent power issues.

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