Inspection finds multiple quality system failures at Neurotone Systems.(MEDICAL DEVICES)

Neurotone Systems, Garland, TX Dallas District

Neurotone Systems, a manufacturer of cranial electrotherapy stimulators, netted a 13-item FDA 483 from investigators Charles Brown and Rebecca O'Bryan, who found a widespread lack of controls, procedures and record-keeping.

The FDAers observed that the firm's management had not ensured that an adequate and effective quality system had been fully implemented at all levels of the company. Neurotone had no written procedures for conducting quality audits and had also failed to conduct any quality audit of its contract supplier of circuit boards for one of its devices, the 483 stated.

The firm also had not developed written procedures for design control for the electrotherapy stimulators, the investigators observed. There was no documentation of design control for design planning, input, output, review, design change from RelaxPak to Neurotone model III and to model III D, verification or validation, Brown and O'Bryan wrote.

Neurotone also failed to provide documentation that the software used in the Neurotone III D device had been validated, and management "was unable to verbally confirm that the software validation had been conducted," the team added. In addition, the company had not developed written assembly procedures for the Neurotone III and Neurotone III D.

The company also did not have written procedures for document approval and document changes regarding the manufacture of the Neurotone III and Neurotone III D devices. The FDAers observed that "the firm does not have a completed Device Master Record and Quality System Records for these devices."

FDA further found that Neurotone had not established procedures for finished device acceptance. "For example, although your firm verbally stated that it manufactured and tested each CES device, you could not provide any records of the test results for the final product testing," the agency wrote in a follow-up warning letter to the firm.

Neutrotone failed to provide written procedures for evaluating suppliers, contractors and consultants it used in manufacturing its devices, the report added. "The firm did not have written data that clearly described or referenced the specified requirements, including quality requirements, for purchased or otherwise received products and services," the FDA team wrote. Nor did the firm have written agreements, contracts or terms or conditions with its contract supplier of circuit boards and other raw materials. FDA also noted in the warning letter that Neurotone had no written procedures for documentation, inspection, testing or verification of incoming product, nor for "addressing how the devices or printed circuit boards are to be reworked or retested for acceptance and where the results of the rework are to be documented."

The investigators found that Neurotone had no written procedures for implementing CAPA for documenting and analyzing quality audit reports, service records, complaints and returned products; for investigating the cause of nonconformities in products and the quality system; and for implementing and recording changes in methods and procedures necessitated by quality problems. Neurotone acknowledged this lack of CAPA procedures.

Neurotone also failed to provide written procedures for complaint handling, the inspection revealed. Although the firm's management confirmed that there had been problems with some of its units, "there was no complaint documentation of these issues. Management stated that these complaints did not involve medical problems, and therefore did not result in review, evaluation or investigation," the team wrote.

The company further failed in providing procedures for maintenance of device history records, the inspectors observed. "Management verbally informed FDA that there were no device history records for their products."

Finally, Brown and O'Bryan wrote, the firm also failed to provide written procedures for developing, maintaining and implementing medical device reports. The warning letter noted that the firm did not have "a standardized review process and procedures to determine whether incoming complaints meet the criteria for an MDR reportable death, serious injury or malfunction," and that Neurotone did not require that MDR reportable events be promptly reviewed, evaluated and reported to FDA. Neurotone's management confirmed the lack of MDR procedures.

Neurotone replied to the 483 observations and warning letter with a detailed list of corrective actions for its quality system. The company committed to establishing "quality system procedures for all quality system processes," including design control, complaint handling and MDR, among others. Neurotone also stated it would establish a design history file and device master record for the Neurotone III D and establish a quality policy and quality objectives "and implement management review and quality system audit activities" to monitor the effectiveness of corrections to the quality system.

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