Menasha Packaging Company LLCFebruary 18, 2025

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

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Record Details

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.

Company: Menasha Packaging Company LLC
Inspection Date: February 18, 2025
Product Type: Other
Office: New Jersey District Office
Person: Esteban Beltran

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ID · 54d46cb8-51a1-4443-853f-44dfd5207910