FDA 483 - TRI-PAC, INC. - November 08, 2024

An FDA inspection of TRI-PAC, INC. in South Bend, IN, revealed a significant issue regarding the sampling of incoming drug components. The firm failed to conduct sufficient identity testing for incoming shipments of Glycerin, a high-risk component for Ethylene Glycol and Diethylene Glycol contamination. This deficiency impacts multiple products manufactured by the firm, including Antimicrobial Foam Skin Cleanser and Moisturizing Foam Hand Sanitizer.