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Posted November 24, 2021

FDA Warns Sanitizer Corporation For Manufacturing and Misbranding Violations

On September 24, 2021, the FDA issued a warning letter to Chameleon Beverage Co. Inc. dba Chameleon Sanitizer Corporation following an inspection of the facility, which found the company's products to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices (cGMP).

These violations include a lack of controls in place to prevent contamination of the production environment, failure to perform release testing before distributing the product, and failure to establish written procedures for cleaning and maintenance of equipment.

In addition, the product ALKEMI HAND SANITIZER GEL is misbranded because it was promoted with drug claims. For example, the product label states, "Drug Facts... Uses: hand sanitizer to reduce bacteria on the skin... Directions: wet hands thoroughly with product and allow to dry without wiping." This product was also warned for its 33.88 oz packaging, which resembles drinking water plastic bottles and poses the risk of consumption.

The FDA first warned consumers about hand sanitizers that are packaged in food and drink containers in September of 2020.

Learn more about hand sanitizers in ConsumerLab's article about coronavirus and disinfection.

For more information, use the link below.

WARNING LETTER : Chameleon Beverage Co. Inc. dba Chameleon Sanitizer Corporation

See related recalls and warnings:

Infuscience, Inc. Warned for Unsanitary Production Practices

Limar Hand Sanitizers Recalled

Prairie Wolf Hand Sanitizer Recalled

Hand Sanitizer Recalled Because Packaging Resembles Water Bottle

Hand Sanitizers Marketed for Children Packaged in Containers Resembling Food and Drink Recalled