FDA 483 - Massco Dental - August 18, 2016

An FDA inspection of Macco Dental, a human pharmaceutical manufacturer in Rogers, AR, revealed significant deficiencies in their manufacturing processes. Observations included inadequate identification and traceability of equipment used in production, such as digital thermometers and containers. Additionally, the firm failed to validate methods for measuring glycerin weight, leading to concerns about process control and product consistency for their oral care pharmaceutical products.