Grupo Plast-Y-Kosas, SA de CV – FDA Warning Letter, Sep 9, 2020

The FDA issued a Warning Letter to Grupo Plast-Y-Kosas SA de CV, a human drug manufacturer in Mexico, following the detention and refusal of admission of their hand sanitizer products (M HAND SANITIZER, Jalisco Paper Inc. HAND SANITIZER, and O.K. PHARMACY HAND SANITIZER) into the U.S. The letter, dated January 25, 2021, details significant adulteration, unapproved new drug, and misbranding violations.

FDA testing revealed M HAND SANITIZER, labeled with 80% ethanol, contained only 0.87% ethanol and 15% methanol, a toxic substance. Jalisco Paper Inc. HAND SANITIZER and O.K. PHARMACY HAND SANITIZER, also labeled with 80% ethanol, contained only 8.6% and 9.2% ethanol, respectively, falling below the recommended 60% minimum. These findings indicate a failure of the firm's quality assurance system to comply with Current Good Manufacturing Practice (CGMP) requirements, leading to adulterated products under sections 501(d)(2) and 501(c) of the FD&C Act.

Furthermore, all three products are considered unapproved new drugs under section 505(a) and misbranded under sections 502(a) and (ee) of the FD&C Act, as they