Nalge Nunc International Corporation – FDA EIR, Dec 15, 2021

An FDA inspection of Nalge Nunc International Corporation in Rochester, NY, was conducted from December 13-15, 2021. This inspection, part of the FY22 medical device workplan and focusing on Class I and II devices like the Nunc IVF Center Well Dish, identified a critical deficiency. A formal observation was issued on an FDA Form 483, citing inadequate establishment of procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, a consumer complaint (PR ID 495832) was not handled promptly or investigated adequately, showing discrepancies in dates and being closed without the device's return. Additionally, two discussion items highlighted issues where corrected or re-worked materials approved for distribution were not available for review, and complaint investigations lacked specific unique device identifier (UDI) information. Management committed to implementing corrective actions for all noted items, including ensuring timely and thorough complaint handling, proper documentation for re-worked products, and inclusion of device identification in complaint records. The FDA emphasized the potential legal sanctions under the Food, Drug and Cosmetic Act.