FDA WARNING_LETTER - Simex Logistics S.A. de C.V. - October 07, 2020

The FDA issued a Warning Letter to Simex logistics S.A. de C.V. on January 28, 2021, following the detention and refusal of admission of their HEALTH & HAND GEL HAND SANITIZER product at the U.S. border. FDA testing of lot #0720 revealed the product contained an average of 51% ethanol, significantly below the labeled 70% and the CDC-recommended minimum of 60%.

This subpotency led to multiple violations: 1. **Adulteration:** The product's strength, purity, or quality fell below its purported representation (Section 501(c) of the FD&C Act). 2. **CGMP Violations:** The subpotency and provided documents indicated the firm's quality assurance was not functioning per Current Good Manufacturing Practice (CGMP) requirements (Section 501(a)(2)(B)). Specifically, the firm released lots without finished product testing (21 CFR 211.165), used an unsuitable refractometer for in-house testing, and performed no objectionable microbiological contamination testing. 3. **Unapproved New Drug:** The hand sanitizer is considered a "new drug" not generally recognized as safe and effective (GRASE) and lacks FDA approval (Section 505(a) and 301(d)). It does not conform to the 1994