FDA WARNING_LETTER - Botanicals Internacional S.A. de C.V. - February 09, 2021

The FDA issued a Warning Letter to Botanicals Internacional S.A. de C.V. on February 3, 2021, after their 'inatek HAND SANITIZER' product was detained at the U.S. border. FDA testing revealed the product, labeled for 70% ethyl alcohol, contained 75% methanol and only 0.2% ethyl alcohol, leading to severe violations. The product is adulterated under section 501(d)(2) of the FD&C Act due to methanol substitution and under 501(a)(2)(B) for demonstrating a failure in the firm's quality assurance and CGMP compliance. It is also an unapproved new drug, violating section 505(a), as it is not GRASE and fails to conform to the 1994 Tentative Final Monograph or meet 505G(a)(3) conditions. Methanol is an unacceptable ingredient. Furthermore, the product is misbranded under sections 502(j), (a), (e), and (ee) of the FD&C Act because it is dangerous to health, its labeling is false/misleading about active ingredients, it fails to list methanol, and it does not comply with nonprescription drug requirements. The FDA demands an updated investigation into the methanol substitution, a CGMP failure analysis, specific CAPA, a list of all U.S.-shipped batches, complete batch records, raw material lists, and an explanation of quality system failures. All firm drugs are on Import Alert 66-78. The FDA strongly recommends engaging a qualified consultant. A response is required within 15 working days.