FDA 483 - Gentell, Inc - August 25, 2015

An FDA inspection of Gentell, Inc. in Bristol, PA, revealed significant deficiencies across its medical device quality system, particularly concerning the manufacturing and distribution of wound gauze and gel products. The firm failed to establish and maintain fundamental quality system elements, including management review, quality audits, CAPA, MDR, complaint handling, device records, process validation, environmental controls, equipment maintenance, and labeling. These widespread issues indicate a severe lack of control over critical aspects of medical device production.