# FDA 483 - Menasha Packaging Company LLC - February 18, 2025

Source: https://www.globalkeysolutions.net/records/483/menasha-packaging-company-llc/54d46cb8-51a1-4443-853f-44dfd5207910

> FDA 483 for Menasha Packaging Company LLC on February 18, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Menasha Packaging Company LLC
- Inspection Date: 2025-02-18
- Product Type: other
- Office Name: New Jersey District Office
- Summary: Menasha Packaging Company LLC in Edison, NJ, a contract manufacturer and repackager/relabeler, received a Form FDA-483 with four observations. The inspection revealed inadequate procedures for environmental control of medical devices, incomplete execution of change control processes, a lack of auditor independence in quality audits, and insufficient attendance at management review meetings. These findings indicate significant weaknesses in the firm's quality system.

## Related Officers

- [Esteban Beltran](https://www.globalkeysolutions.net/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.globalkeysolutions.net/companies/menasha-packaging-company-llc/916f4181-9817-4eab-aad5-e33aa00515d3

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248