FDA 483 - Applied Laboratories, Inc. - October 27, 2023

An FDA inspection of Applied Laboratories, Inc. in Columbus, IN, a drug manufacturing facility, revealed significant deficiencies in quality control. Observations included a failure to verify the identity of high-risk drug components, inadequate sampling and testing of raw materials, and equipment design issues that could lead to metal contamination in drug products. These findings indicate serious concerns regarding the safety and quality of manufactured drug products.