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FDA Warns Phototherapy Device Maker for Quality System Issues

Posted 19 July 2017 | By Michael Mezher 

FDA Warns Phototherapy Device Maker for Quality System Issues

The US Food and Drug Administration (FDA) has warned device maker National Biological Corporation for quality systems issues following a two-week inspection of the firm's Beachwood, OH facility last March.

The warning letter, dated 11 July 2017, details eight violations, including validation, recordkeeping and equipment calibration issues.

FDA also says the company failed to notify it within 10 days of issuing a recall for one of its devices, and did not do so until the inspection was already underway.

"On January 17, 2017, your firm conducted a recall on one work order of UVB-138 phototherapy devices because the lamps were incorrectly wired to turn on with the key rather than with use of the timer. The potential hazard associated with this device problem is overexposure of UV light, which can lead to skin burns," FDA writes.

According to FDA, National Biological failed to validate processes and equipment used in the manufacture of its phototherapy devices, including multiple crimping machines and the gluing and curing process used for the Dermalume 2x device.

The agency also says the company's procedures for nonconforming products and materials do not ensure that all nonconformances receive an evaluation, including a determination of whether an investigation is necessary.

Specifically, FDA says the company did not evaluate whether an investigation was necessary in 500 instances of nonconforming products or materials that were marked "scrap, return to vendor or 'use as is.'"

FDA says that the company's plan to review the issue is inadequate, as it only proposes to review instances of nonconforming materials from 2017.

"A review of 4 months of records does not appear adequate. Typically, a 2-year retrospective review of records is performed," FDA writes.

FDA also says the company's procedures do not assure that all complaints are reviewed and evaluated, and that the company did not list potential hazards identified in two complaints in its Hazard Analyses Worksheet.

Additionally, FDA cites the company for failing to document rework and reevaluation activities in its device history records. "A total of three of the six nonconformance reports that document rework for in-process nonconformances could not be linked to a device history record," FDA writes.


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