FDA WARNING_LETTER - Dynamic Blending Specialists, Inc. - December 06, 2024

On June 18, 2025, the FDA issued a Warning Letter to Dynamic Blending Specialists, Inc. following an inspection from December 3-6, 2024, at their Vineyard, Utah facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to test drug components (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm did not adequately identity test components like glycerin (high-risk for DEG/EG contamination), stannous fluoride, menthol, and camphor, nor did they validate supplier COAs. The FDA deemed their response inadequate, lacking detailed plans, timelines, and a retrospective review of distributed products. Required actions include detailed testing plans, DEG/EG testing of retains within 30 days, a full risk assessment for in-expiry products, and a comprehensive review of the material system. 2. **Inadequate laboratory controls (21 CFR 211.160(b)):** Sampling plans for products like SmileSense Fluoride Toothpaste and KT Tape Pain Relief Gel were insufficient to assure quality, lacking justification for representativeness. The firm also failed to monitor its water system for conductivity or microbiology