GentellDecember 16, 2019

FDA 483 - Gentell - December 16, 2019

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Record Details

Gentell, a medical device firm in Bristol, PA, was cited for failing to ensure the appropriate design, construction, placement, and installation of manufacturing equipment. Specifically, their labeling system for wound cleanser was not qualified for its intended use, including maintenance and calibration requirements.

Company: Gentell
Inspection Date: December 16, 2019
Product Type: Device
Office: Philadelphia District Office
Person: Edward D. McDonald (Investigations)

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ID · 67927409-bc63-46ee-9749-c1b8f06f6dc9