Impacta Hand Sanitizer Illegal: FDA

FDA says its laboratory testing of Impacta Health Hand Sanitizer manufactured by Guangzhou Shiruoni Cosmetics Co., Guangzhou, Guangdong, China, determined that it was adulterated and misbranded. A 12/7 Warning Letter says the hand sanitizer is adulterated due to violations of Current Good Manufacturing Practice (CGMP) requirements and misbranded because laboratory testing showed it contained an average of 67% volume/volume ethanol and 0% isopropyl alcohol, even though it was labeled to contain 75% volume/volume isopropyl alcohol.

In the letter, FDA says it recommends that the firm engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements if it intends to resume manufacturing drugs for the U.S. market.

The company’s products were placed on an import alert 3/10. Guangzhou was told to respond with a list of specific actions it has taken to address any violations and prevent their recurrence.