Hou Fu Biotech - Jiangsu Co., Ltd

Warning LetterOpen

Ms. Angie Walter Dual Health Body and Mind 188 5th Creek Road Statesville , NC 28625 United StatesIssued Apr 12, 2021Center for Drug Evaluation and Research

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations4

Issue DateApr 12, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Hou Fu Biotech - Jiangsu Co., Ltd
Location: Ms. Angie Walter Dual Health Body and Mind 188 5th Creek Road Statesville , NC 28625 United States
FEI Number: N/A
Country: United States
Issue Date: April 12, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

Summary

This closeout letter addressed Dual Health Body and Mind's corrective actions following an initial warning issued in May 2018 regarding dietary supplements. The company had been cited for violations related to unapproved new drug claims, misbranding, and adulteration. The April 2021 closeout letter indicated that the firm had adequately addressed the original violations, though the FDA reserved the right to conduct future inspections and take additional regulatory action if compliance lapses were discovered.

Hou Fu Biotech - Jiangsu Co., Ltd FDA Warning Letter, April 12, 2021