FDA WARNING_LETTER - Salon Technologies International, Inc - February 07, 2023

The FDA issued a Warning Letter to Salon Technologies International, Inc. on December 21, 2022, following FDA laboratory testing and the firm's own impurity test results of their consumer antiseptic hand rub drug products. The firm, registered as a human drug manufacturer, distributed Salon Technologies International Sanitizing Hand Spray 80% and Antica Farmacista Hand Sanitizer Ocean Citron in the U.S.

The FDA found Salon Technologies International Sanitizing Hand Spray 80% contained unacceptable levels of acetaldehyde (739 ppm) and acetal (988 ppm), exceeding the USP limit of 10 ppm for alcohol. The firm's own testing revealed Antica Farmacista Hand Sanitizer Ocean Citron contained 12 ppm of benzene, a known human carcinogen. These findings indicate the drug products are adulterated under section 501(a)(2)(B) of the FD&C Act, demonstrating a failure in the firm's quality assurance and non-compliance with Current Good Manufacturing Practice (CGMP) requirements.

Specifically, the firm failed to establish specifications for acetaldehyde, acetal, and benzene per 21 CFR 211.160(b) and conduct finished product testing for each batch as required by 21 CFR 211.165. The FDA had previously informed the firm of these issues and recommended removing adulterated batches from the market. The firm initiated