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

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.