FDA EIR - Nalge Nunc International Corporation - September 26, 2018

An FDA inspection of Nalge Nunc International Corporation, a medical device manufacturer in Rochester, NY, was conducted from September 21-26, 2018. This abbreviated inspection, part of the FY18 medical device workplan, assessed compliance with medical device regulations, including the Quality System Regulation (specifically 21 CFR 820.100(a) for Corrective and Preventive Action). The company manufactures Class 1 and Class 2 medical devices, including IVF dishes. The inspection notably found that 13 observations from a previous 2013 inspection, particularly concerning design controls, appeared to have been corrected. The inspection resulted in a single observation on an FDA Form 483: "Procedures for corrective and preventive action have not been adequately established." Specifically, corrective actions for a customer complaint regarding IVF dishes shipped without lids were not formally tracked within the CAPA system to ensure their effectiveness. Additionally, inconsistent risk assessments for similar nonconformances concerning IVF dish seal issues led to failures in initiating required CAPA actions. Management also discussed two additional items: partially blocked air return vents and unmarked floors in an ISO Class 7 Cleanroom, which were promptly corrected and verified during the inspection, and an unclear definition of risk likelihood in their risk management procedure. Management committed to providing a written response to the FDA detailing planned corrections for the CAPA observation and revising the risk management procedure within a month.