FDA 483 - Gentell, Inc - December 12, 2019

Gentell, Inc., a medical device manufacturer in Bristol, PA, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included unvalidated manufacturing processes for Honey Hydrogel, lack of finished product testing and stability studies, and inadequate environmental controls. Furthermore, the firm failed to establish an adequate organizational structure, conduct management reviews, perform internal quality audits, or ensure proper personnel training.