Bionateo Sp. z.o.o. Warning Letter Details

Summary

Bionateo Sp. z.o.o., a Polish drug manufacturer, was cited for manufacturing ALTAIO HAND SANITIZING GEL, an unapproved antiseptic hand rub product that violated multiple regulations including being adulterated, misbranded, and an unapproved new drug. FDA laboratory testing of a detained batch revealed unacceptable contamination levels, including methanol impurities between 625-2,500 ppm and approximately 0.88% undeclared ingredients, demonstrating that the company's quality assurance and current good manufacturing practice (CGMP) controls were not functioning adequately. The product was detained and refused admission at the U.S. border following an attempted import.