WARNING LETTER
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd.
MARCS-CMS 628678 —
July 20, 2022
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
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
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Warning Letter
320-22-21
July 20, 2022
Dear Ms. Zhifang Jiang:
Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products including hand sanitizers, specifically, Orchard de Flore INSTANT HAND SANITIZER and artnaturals HAND SANITIZER. A review of import records showed multiple shipments of OTC drug products into the U.S. which declared Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. as the drug manufacturer. On August 9, 2021, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail address provided in your registration file. This request went unanswered. A second request was sent via e-mail on August 27, 2021, followed by a telephone conversation with your registered U.S. Agent on October 26, 2021, regarding this matter. The Agency sent a follow-up written request for such records and other information on November 24, 2021. Delivery to you was confirmed by the shipper, but you failed to respond to these attempted communications or otherwise provide the requested records or other information. Pursuant to section 704(a)(4), FDA’s request and follow-up communication included a sufficient and clear description of the records sought.
It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a).
Since the declaration of the COVID-19 public health emergency,
1
a number of hand sanitizer drug products have been recalled due to quality issues ranging from substitution with other drug substances to subpotency.
2
The Agency has reached out to registered OTC drug firms with hand sanitizers drug products included in their product listing to assess the overall quality of the drugs registered as manufactured by these firms. Because your OTC drug firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs registered as manufactured at your facility.
FDA placed all drugs and drug products manufactured by your firm on Import Alert 66-79 on May 16, 2022.
Until FDA is able to confirm compliance with CGMP and other applicable requirements, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd., No. 38 Liansheng Industrial Pack, Hongqi Village, Qinghong Road, Guangzhou, Guangdong into the United States that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
On June 8, 2022, FDA notified the public at the following website that you failed to respond to multiple FDA requests for records related to drug manufacturing and product quality, and that drugs and drug products from your facility had been added to Import Alert 66-79 on May 16, 2022, to urge consumers not to use your hand sanitizer drug products at the following website:
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use
After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may provide information for our consideration as we continue to assess your activities and practices, and/or submit a request to schedule an FDA inspection.
Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012368173 and ATTN: Christina Capacci-Daniel.
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research, FDA
CC:
Registered U.S. Agent:
David Lennarz
Registrar Corp
144 Research Drive
Hampton, VA, 23666
757-224-0177
drugs@registrarcorp.com
CC:
Mr. Yosef Nourollah
CEO
Virgin Scent, Inc.
dba
Artnaturals
2390 Crenshaw Blvd, PMB #702
Torrance, CA 90501
_______________________
1
The HHS Declaration of a Public Health Emergency is available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx
.
2
In March 2020, the Agency published three guidance documents to provide regulatory flexibility to certain firms to help meet the demand for alcohol-based hand sanitizer during the COVID-19 public health emergency (PHE). Additionally, on December 31, 2021 these guidances were withdrawn, and firms were required to cease distribution, by March 31, 2022, of any remaining hand sanitizer products that were prepared under the temporary policies before or on December 31, 2021. See, 86 FR 56960, October 13, 2021.
Content current as of:
07/26/2022
Regulated Product(s)
Drugs