FDA 483 - Dynamic Blending Specialists, Inc. - December 06, 2024

Dynamic Blending Specialists, Inc. in Vineyard, UT, a drug manufacturer, was inspected and received six observations primarily concerning inadequate quality control, laboratory controls, and equipment maintenance. Key issues include a lack of raw material testing, insufficient supplier qualification, poor documentation practices, and absent stability testing programs for drug products. The findings indicate significant deficiencies in ensuring product quality, identity, strength, and purity.