Increasing Number of FDA Warning Letters in the Area of Hand Disinfection

We had already reported recently on the FDA's publications regarding the increasing problems with various hand disinfectant manufacturers, e.g. "FDA stops further supply of hand disinfectant at the US border", "Warnings of side effects and contamination in hand disinfectants" or "Warning letter from the FDA for contaminated hand disinfectants".

Thus, as a result of the increased demand during the pandemic emergency, more and more manufacturers with inadequate quality systems for the production of hand disinfectants seem to have tried to get a piece of the pie. This impression is confirmed by an increasing number of Warning Letters from the FDA. In September and October alone, Warning Letters followed to various companies:

  • Ardil Comercial S.R.L in the Dominican Rebublic for adulterated product in which ingredients were substituted, containers resembling beverage containers and because the claim was that of a new drug without the corresponding approval.
  • Limpo Quimicos, SA de CV, Mexico, which had also replaced ingredients with other substances and wanted to introduce the products without the corresponding authorisation.
  • Die Notarika, S.A. de C.V., also from Mexico also with the wrong composition and lack of approval.
  • GuangZhou YouXing Cosmetic Co., Ltd from China, sold a product which contained only 35% ethanol instead of 75% ethanol, and also had registration deficiencies and labelling violations.
  • Chameleon Beverage Co. Inc. dba Chameleon Sanitizer Corporation had discrepancies in hygiene standards and also errors in the claim of the label and the clear colourless product is packaged in bottles that look like drinking water bottles. This is misbranding in relation to the requirement to avoid misleading packaging.
  • Global Sanitizers LLC had 70% ethanol listed as the active ingredient, but in the samples tested, one contained 0% ethanol, but 58% methanol, and another contained only 32% ethanol and 7.4% methanol. Methanol poses a hazard to the user.

It can be assumed that more cases will follow and that the US controls will end in import bans and Warning Letters.

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