483
GentellFDA 483 - Gentell - December 16, 2019
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.
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ID · 67927409-bc63-46ee-9749-c1b8f06f6dc9