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DDI Multinacional S.A. de C.V. was warned about manufacturing unapproved hand sanitizer products (EARTHS AMENITIES Hand Sanitizer and AGAVESPA skincare HAND SANITIZER) that violated multiple sections of the Federal Food, Drug, and Cosmetic Act. FDA testing revealed the products were adulterated due to substance substitution and demonstrated that the company's quality assurance systems were not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements. The products were also misbranded and classified as unapproved new drugs, resulting in their detention and refusal of admission at the U.S. border.