FDA 483 - Kobayashi America Manufacturing, LLC - March 15, 2024

An FDA inspection of Kobayashi America Manufacturing, LLC in Dalton, GA, from March 11-15, 2024, revealed that drug products lacked expiration dates supported by adequate stability data. Specifically, the firm failed to perform microbial testing and preservative content testing during stability studies for several OTC drug products, including Zim's Max Freeze Gel and Roll-On.