# FDA 483 - Nalge Nunc International Corporation - January 05, 2024

Source: https://www.globalkeysolutions.net/records/483/nalge-nunc-international-corporation/75c9a95e-3d17-4b51-be1e-d8525b48d1da

> FDA 483 for Nalge Nunc International Corporation on January 05, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nalge Nunc International Corporation
- Inspection Date: 2024-01-05
- Product Type: device
- Office Name: New York District Office
- Summary: Nalge Nunc International Corporation, a medical device manufacturer in Rochester, NY, received a Form FDA 483 with two observations. The inspection revealed deficiencies in the validation of software used for automated injection molding and inadequate establishment of equipment maintenance schedules for production machinery. These issues indicate potential concerns with quality system controls for manufacturing medical devices.

## Related Documents

- [483 - 2021-12-15](https://www.globalkeysolutions.net/records/483/nalge-nunc-international-corporation/d60c6a1d-a926-4cdb-a80d-2d6bb6d40799)

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

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

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d