FDA 483 - Formulation Technology, Inc. - March 21, 2025

An FDA inspection of Formulation Technology, Inc. in Oakdale, CA, a dietary supplement and drug manufacturer, revealed significant deficiencies across multiple areas of its operations. The firm failed to implement effective contamination prevention measures, exhibited poor quality control unit oversight, and neglected proper equipment calibration and maintenance. Additionally, widespread employee training failures were noted, indicating a serious lack of adherence to current Good Manufacturing Practices.