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Talk to a SpecialistTalk to a SpecialistSalon Technologies International, Inc. was cited for manufacturing adulterated antiseptic hand rub products, including Salon Technologies International Sanitizing Hand Spray 80% and Antica Farmacista Hand Sanitizer Ocean Citron, due to unacceptable levels of impurities in distributed batches. FDA testing found acetaldehyde at approximately 739 ppm and acetal at approximately 988 ppm in the hand spray product, both far exceeding the USP specification limit of 10 ppm for these alcohol impurities. The violations indicated that the company's quality assurance system was not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements, rendering the products adulterated under the Federal Food, Drug, and Cosmetic Act.