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

Source: https://www.keypedia.com/records/483/nalge-nunc-international-corporation/d60c6a1d-a926-4cdb-a80d-2d6bb6d40799

> FDA 483 for Nalge Nunc International Corporation on December 15, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nalge Nunc International Corporation
- Inspection Date: 2021-12-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

## Related Documents

- [483 - 2024-01-05](https://www.keypedia.com/records/483/nalge-nunc-international-corporation/75c9a95e-3d17-4b51-be1e-d8525b48d1da)

## Related Officers

- [investigator](https://www.keypedia.com/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

Company: https://www.keypedia.com/companies/nalge-nunc-international-corporation/97763e4a-ce32-4573-a31a-39c58cf76fe3

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961