Nalge Nunc International CorporationDecember 15, 2021

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

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Record Details

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.

Company: Nalge Nunc International Corporation
Inspection Date: December 15, 2021
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Wendy M. Stone (investigator)

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ID · d60c6a1d-a926-4cdb-a80d-2d6bb6d40799