WARNING LETTER
Zhao Qing Longda Biotechnology Co. Ltd.
MARCS-CMS 664934 —
September 18, 2023
Delivery Method:
VIA UPS
Reference #:
320-23-39
Product:
Drugs
Recipient:
Recipient Name
Elben
Zhao Qing Longda Biotechnology Co. Ltd.
No. 20 Yingbin Road
Gaoxin District
Zhaoqing Shi
Guangdong Sheng
,
526238
China
2112257989@qq.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Warning Letter 320-23-39
September 18, 2023
Reference FEI 3014354419
Dear Elben:
Your firm was registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products, including toothpaste for children. Ingredients of the drugs registered as manufactured at your firm include ingredients susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) substitution. A review of import records showed multiple shipments of drug products into the United States, which declared Zhao Qing Longda Biotechnology Co. Ltd., as the drug manufacturer. On March 17, 2023, 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 email address provided in your registration file. This request went unanswered. Second and third requests were sent via email on April 6 and April 18, 2023. On April 19, 2023, you responded stating that you were “not prepared to allow the FDA to audit and inspect” your firm. The Agency sent a follow-up written request for such records and other information on April 28, 2023, to your registered address on file; however, we received a delivery failure notification. Pursuant to section 704(a)(4), FDA’s request and follow-up communications 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).
The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document
Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
to help you meet the current good manufacturing practice (CGMP) requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.
Because your 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.
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 Zhao Qing Longda Biotechnology Co. Ltd., No. 20 Yingbin Road, Gaoxin District, Zhaoqing Guangdong, 526238 China 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).
FDA placed all drugs and drug products manufactured by your firm on Import Alert 66-79 on August 29, 2023.
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 #3014354419 and ATTN: Matthew R. Dionne, Pharm.D., Compliance Officer.
Sincerely,
/S/
Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research, FDA
CC:
Registered U.S. Agent:
APAX International, Inc.
James@sino2us.com
Content current as of:
09/26/2023
Regulated Product(s)
Drugs