FDA 483 - Formulation Technology, Inc. - January 10, 2020

An FDA inspection of Formulation Technology, Inc. in Oakdale, CA, revealed significant deficiencies in data integrity and quality control for their drug manufacturing operations. The firm failed to implement appropriate controls for computer systems used in potency testing, leading to unverified data. Additionally, the Quality Control Unit did not follow established procedures for product quality reviews and preventative maintenance for manufacturing equipment.