Radiation Safety Apparel Maker Fails to Report Complaints

August 5, 2019

Devicemaker Protech Leaded Eyewear failed to develop Medical Device Reporting procedures and didn’t investigate complaints, the FDA’s Dec. 6-14, 2018 inspection of its Lake Park, Florida plant revealed.

The maker of radiation safety apparel received numerous complaints about broken lenses in its safety glasses, holes in protective gloves, and many of these “were not reviewed, evaluated or investigated. Some of these complaints, especially the glove failures, could be MDR reportable,” the Form 483 said.

The firm didn’t analyze processes, work operations, quality records, service records, complaints, returned product and other sources of quality data to identify potential causes of the nonconforming product, the FDA said.

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