483
Menasha Packaging Company LLCMenasha Packaging Company LLC – FDA 483, Feb 18, 2025
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.
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ID · 54d46cb8-51a1-4443-853f-44dfd5207910
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