FDA WARNING_LETTER - Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. - July 26, 2022

The FDA issued a Warning Letter to Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd., a registered manufacturer of OTC hand sanitizers, including Orchard de Flore INSTANT HAND SANITIZER and artnaturals HAND SANITIZER. The letter details the firm's failure to respond to multiple requests for records and other information, initiated by the FDA in August and November 2021, pursuant to section 704(a)(4) of the FD&C Act. This refusal to permit access to or copying of records is cited as a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)). Due to the firm's non-response, the FDA lacks assurance regarding the quality of drugs manufactured at the facility. As a result, all drugs from the firm were placed on Import Alert 66-79 on May 16, 2022, making future shipments subject to detention or refusal. The FDA also publicly advised consumers not to use the firm's hand sanitizer products. The firm must respond within 15 working days, providing information or requesting an FDA inspection, to address these compliance issues.