FDA 483 - Cayman Chemical Company, Inc. - December 03, 2018

An FDA inspection of Cayman Chemicals Company, Inc. in Ann Arbor, MI, conducted from November 27 to December 3, 2018, identified a significant quality control deficiency. The firm failed to perform required growth promotion testing on growth media used for environmental monitoring during API packaging activities. This indicates a potential risk to product quality and environmental control.