Formulation Technology, Inc. – FDA 483, Nov 9, 2023

Formulation Technology, Inc. in Oakdale, CA, a dietary supplement manufacturer, received a Form 483 for significant deficiencies in their quality control and specification establishment. The inspection revealed failures to establish adequate identity, purity, strength, and composition specifications for both components and finished products, along with a lack of contamination limits. Additionally, quality control personnel failed to properly approve or reject specifications, indicating systemic issues in their quality system.