FDA 483 - Kobayashi America Manufacturing, LLC - May 27, 2022

Kobayashi America Manufacturing, LLC, an own label distributor in Dalton, GA, was cited for significant deficiencies in its quality control unit's oversight of contract manufactured OTC drug products. The inspection revealed failures in batch record review, stability data evaluation for expiration dating, microbiological testing, complaint handling, temperature monitoring for storage, and labeling control. These issues indicate a lack of robust quality assurance for drug products.