FDA WARNING_LETTER - Dr. Brite LLC - April 05, 2024

The FDA issued a Warning Letter to Dr. Brite, LLC following an inspection from April 2-5, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to test components:** The firm did not adequately test incoming components, especially glycerin, for identity, purity, strength, and quality, including for diethylene glycol (DEG) and ethylene glycol (EG) contamination, which are high-risk impurities. 2. **Inadequate finished product release testing:** The firm failed to conduct appropriate laboratory determination of satisfactory conformance to final specifications for drug products, including identity and strength of active ingredients and testing for objectionable microorganisms. 3. **Quality Control Unit deficiencies:** The Quality Control Unit failed to ensure CGMP compliance, adequate production and process controls, an adequate stability program, maintained batch production records, and proper employee training.

Additionally, several products, including "Dr. Brite® Kids Anti-Plaque Toothpaste," "Dr. Brite® Extreme Whitening Toothpaste," "Dr. Brite® Healthy Gums Toothpaste," "Dr. Brite® Kids Anti-Plaque Mouth Spray," and "Dr. Brite® Kids Mineral Mouth Spray," are cited as **unapproved new drugs** because they contain hydroxyapatite as an active ingredient, which is not a permitted ingredient under applicable OTC monographs for