Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012368173.
Violations0
Issue DateJul 20, 2022
Product TypeOther
StatusOpen
Letter Details
Firm
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd.
Location
Ms. Zhifang Jiang
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd.
No.38 Liansheng Industrial Pack
Hongqi Village, Qinghong Road
Guangzhou Shi
Guangdong Sheng , 510545
China
FEI Number
3012368173
Country
China
Issue Date
July 20, 2022
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Other
Status
Open
Summary
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.
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. FDA Warning Letter, July 20, 2022
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