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Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. was warned for refusing to provide access to and copying of records related to its OTC hand sanitizer drug products (Orchard de Flore INSTANT HAND SANITIZER and artnaturals HAND SANITIZER) in violation of section 704(a) of the Federal Food, Drug, and Cosmetic Act. The company failed to respond to multiple FDA record requests sent via email on August 9, 2021, August 27, 2021, and November 24, 2021, as well as a telephone follow-up on October 26, 2021. The FDA's enforcement action was prompted by the COVID-19 public health emergency context, during which numerous hand sanitizer products had been recalled due to quality issues including drug substance substitution and subpotency.