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Medical Devices / Inspections and Audits

Phototherapy Developer Found Lacking for CAPAs, Supplier Audits

May 28, 2019
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Phototherapy developer National Biological Corp. fell short on several quality management systems, the FDA said following a Feb. 4-14 inspection of its Beachwood, Ohio plant.

Validation studies were sloppy in that equipment settings and variables were not used, and not all wire/terminal combinations were tested for the company’s phototherapy devices. In addition, the firm’s supplier had not validated its process, the Form 483 said.

National Biological also failed to investigate complaint files and many were documented as “results of normal wear.” In one case, a sensor was replaced but no investigation was conducted, the FDA said.

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