dunagin pharmaceuticals inc. – FDA Warning Letter, Sep 2, 2022

The FDA issued a Warning Letter to Dunagin Pharmaceuticals Inc. dba Massco Dental following an inspection from August 29 to September 2, 2022, citing significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Contamination/Mix-ups (21 CFR 211.42(c)):** The firm uses the same equipment for manufacturing drug products (toothpaste, mouth rinse) and non-pharmaceutical materials, risking contamination. The FDA requires discontinuing shared equipment use or providing a plan for dedicated manufacturing areas, along with a risk assessment for all previously produced drugs. 2. **Component Testing (21 CFR 211.84(d)(2)):** The firm relied on supplier COAs without establishing reliability and used non-pharmaceutical grade potassium nitrate. They also lacked specific identity testing for diethylene glycol (DEG) and ethylene glycol (EG) in glycerin, especially concerning for pediatric oral products. The FDA demands a comprehensive review of the material system, detailed testing procedures, COA validation, and DEG/EG testing results for all glycerin lots. 3. **Production and Process Control (21 CFR 211.100(a)):** The firm failed to validate manufacturing processes and adequately maintain equipment (e.g., rusted mixing equipment). The FDA requires a detailed validation program, timelines for process performance