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Industrias Cklass S. de R.L. de C.V. manufactured an unapproved hand sanitizer product labeled "cklass Hand Sanitizer WITH ALOE ENRICHED WITH MOISTURIZING AND EMOLLIENT AGENTS" that was detained at the U.S. border and found to be adulterated due to substance substitution, indicating a failure in quality assurance and Current Good Manufacturing Practice (CGMP) compliance. The product violated multiple FD&C Act provisions by being introduced into interstate commerce as an unapproved new drug and misbranded under sections 502(j), (a), (e), and (ee). FDA laboratory testing demonstrated that the company's quality assurance systems were not functioning in accordance with CGMP requirements.