FDA 483 - OFD Foods LLC - Plant 2 - July 01, 2022

OFD Foods LLC in Albany, OR, a drug manufacturer, was cited for significant deficiencies in laboratory controls, including inadequate microbiological testing and environmental monitoring methods. The inspection also revealed failures in conducting thorough investigations into unexplained discrepancies and product rejections. Furthermore, the firm lacked proper change control for Master Batch Records, leading to inconsistent and unauthorized amendments.