FDA 483 - Nalge Nunc International Corporation - December 15, 2021

An FDA inspection of Nalge Nunc International Corporation in Rochester, NY, revealed a significant issue with their complaint handling procedures. The firm failed to adequately establish and follow procedures for receiving, reviewing, and evaluating complaints, leading to an untimely and insufficient investigation of a specific product complaint. This indicates a deficiency in their quality system related to post-market surveillance.