Albek de Mexico S.A. de C.V. Warning Letter Details

Summary

Albek de Mexico S.A. de C.V. manufactured NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER, an unapproved new drug that was detained at the U.S. border and found to be adulterated due to substance substitution, indicating a failure in quality assurance and compliance with Current Good Manufacturing Practice (CGMP) requirements. The product violated multiple provisions of the Federal Food, Drug, and Cosmetic Act by being introduced into interstate commerce without FDA approval and with false or misleading labeling. FDA laboratory testing of detained batches demonstrated that the company's quality control systems were not functioning adequately to prevent the manufacturing defects.