FDA Issues Warning Letter to Dynamic Blending for Significant CGMP Violations

The U.S. FDA has issued a Warning Letter to Dynamic Blending Specialists, Inc., following a December 2024 inspection of its Vineyard, Utah facility. Inspectors found multiple CGMP violations, especially in sampling and component testing practices. The company failed to conduct identity testing for each component lot, relying instead on unverified supplier COAs. High-risk ingredients like glycerin weren’t tested for contaminants such as diethylene glycol and ethylene glycol. Sampling of finished products was non-representative, lacking supporting studies. Water system monitoring was inadequate, with missing microbiological tests and poorly stored records. Sampling justifications lacked scientific rationale, putting product quality at risk. The Quality Unit was cited for shredded CGMP records, absent non-conformance reports, and undocumented calibration data. Additionally, one product was deemed an unapproved and misbranded drug. The FDA criticized the company’s corrective response as vague and lacking detail, urging it to engage an independent CGMP consultant for a comprehensive audit and remediation.

16-07-2025