David Cosmetic Co., Ltd. – FDA Warning Letter, May 10, 2022

On May 2, 2022, the FDA issued a Warning Letter to David Cosmetic Co., Ltd., a South Korean human drug manufacturer, following FDA laboratory testing of their CALA Advanced Hand Sanitizer Moisturizing with Aloe Vera Extract. The testing revealed unacceptable levels of benzene, approximately 6 ppm, in a batch distributed in the U.S., rendering the product adulterated under section 501(a)(2)(B) of the FD&C Act.

The FDA identified significant Current Good Manufacturing Practice (CGMP) violations. During a December 27, 2021 teleconference, David Cosmetic Co., Ltd. committed to recalling the adulterated batch but, as of the letter's date, had not initiated the recall. Furthermore, the firm admitted in a December 29, 2021 communication that it does not conduct impurity testing, including for benzene, on active pharmaceutical ingredients or finished hand sanitizer products, violating 21 CFR 211.160(b) and 21 CFR 211.165.

The FDA strongly recommended engaging a qualified CGMP consultant to evaluate operations and assist with compliance if the firm intends to resume manufacturing drugs for the U.S. market. All drugs manufactured by David Cosmetic Co., Ltd. were placed on Import Alert 66-78 on March 10, 2022, meaning they may be detained or