Bionateo Sp. z.o.o. – FDA Warning Letter, Apr 22, 2021

On November 4, 2021, the FDA issued a Warning Letter to Bionateo Sp. z.o.o, a human drug manufacturer in Poland, following the detention and refusal of admission of their ALTAIO HAND SANITIZING GEL product into the U.S. The FDA's laboratory testing revealed the product was adulterated, containing unacceptable levels of methanol (625-2,500 ppm) and undeclared isopropanol (0.88% v/v), despite being labeled as 80% ethyl alcohol. Methanol is highly toxic and not an acceptable ingredient.

The product is also an unapproved new drug and misbranded. It is considered a "new drug" because it's not generally recognized as safe and effective (GRASE) and lacks FDA approval. It is misbranded because it's dangerous to health due to methanol, its labeling is false or misleading regarding active ingredients and concentrations, it fails to list all ingredients, and lacks a complete domestic address/phone number for adverse event reporting.

Bionateo Sp. z.o.o has a history of not providing adequate or complete responses to FDA information requests regarding CGMP operations and testing methods. The FDA recommends engaging a qualified CGMP consultant to evaluate operations and assist with remediation. All drugs from Bionateo Sp. z.o.o were placed on Import Alert 66-78 on June 7, 2