Corporativo Bureli S.A. de C.V. – FDA Warning Letter, Sep 24, 2020

On December 1, 2020, the FDA issued a Warning Letter to Corporativo Bureli S.A. de C.V., a newly registered human drug manufacturer in Mexico. The letter details violations concerning Soho Fresh Hand Sanitizer, declared to be manufactured at their facility.

FDA testing of a detained batch of Soho Fresh Hand Sanitizer, labeled to contain 70% ethyl alcohol, revealed it contained less than 0.25% ethanol and approximately 70% methanol. This constitutes adulteration under section 501(d)(2) of the FD&C Act due to active ingredient substitution with a dangerous chemical. The substitution also indicates the firm's quality assurance is not functioning per Current Good Manufacturing Practice (CGMP) requirements, violating section 501(a)(2)(B).

Furthermore, the product is an unapproved new drug, violating section 505(a), and is misbranded under sections 502(j), (a), (e), (x), and (ee) of the FD&C Act. Misbranding includes being dangerous to health due to methanol, false labeling regarding ethanol content, failure to list methanol as an ingredient, and lack of a domestic contact for adverse event reporting.

The FDA recommended a recall and placed all drugs from the firm on Import Alert 66-78 on September 24, 2020, due to CGMP non