FDA 483 - HealthDent'l LLC - December 13, 2018

HealthDent'l LLC, a medical device manufacturer in Plainfield, IL, received one observation during an FDA inspection. The firm failed to document the results of design validation, specifically concerning the impact of shipping temperature variations on the effectiveness of their Hema-Benz dental desensitizer. This indicates a significant lapse in quality system documentation for product design and distribution.