Bionateo Sp. z.o.o.

Warning LetterOpen

Mr. Dominik Wojciechowski Co-Owner Bionateo Sp. z.o.o. Ul. Chocimska 6 Kalisz 62-800 Wielkopolskie PolandFEI 3017231855Issued Nov 4, 2021Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3017231855.

Violations4

Issue DateNov 4, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Bionateo Sp. z.o.o.
Location: Mr. Dominik Wojciechowski Co-Owner Bionateo Sp. z.o.o. Ul. Chocimska 6 Kalisz 62-800 Wielkopolskie Poland
FEI Number: 3017231855
Country: Poland
Issue Date: November 04, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

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.

Bionateo Sp. z.o.o. FDA Warning Letter, November 4, 2021