Suzhou Win Health International Co.,Ltd.
FDA import alert and refusal historyDongtai City, ChinaFEI 3014097022
As of October 27, 2026, Suzhou Win Health International Co.,Ltd. (Dongtai City, China) is on the red list of FDA Import Alert 54-18 (Supplements and ingredients with new dietary ingredients) for higenamine, published by FDA on February 22, 2021, and has 5 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- IA 54-18 · red list
- Last import refusal
- Herbals & botanicals (not teas), n.e.c. · NDIDIETSP
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Suzhou Win Health International Co.,Ltd.
6 records, newest first. Each line links to the FDA page it came from.
2025
2021
- Import refusalSource
Refused, 2 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.NDIDIETSPEntry 799-4248293-5Show 2 linesHide lines
- Import alert listingListed on Import Alert 54-18red listHigenamineSource
2018
- Import refusalRefused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNSFDIETSPEntry AEK-4552335-1Source
Refusal charges, in plain English
- NDIDIETSP4 refused lines
NDIDIETSP
- UNSFDIETSP1 refused line
Dietary ingredient without safety assurance
The product appeared to be a dietary supplement or dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury.
Questions about Suzhou Win Health International Co.,Ltd.
- Is Suzhou Win Health International Co.,Ltd. on an FDA import alert?
- Yes. As of October 27, 2026, Suzhou Win Health International Co.,Ltd. is on the red list of FDA Import Alert 54-18, “Supplements and ingredients with new dietary ingredients”, for higenamine; FDA published the listing on February 22, 2021.
- Has FDA refused shipments from Suzhou Win Health International Co.,Ltd.?
- Yes. FDA refused 5 shipment lines from Suzhou Win Health International Co.,Ltd. between June 7, 2018 and January 10, 2025. The most recent, on January 10, 2025, was herbals & botanicals (not teas), n.e.c., charged as NDIDIETSP (ndidietsp).
- Why did FDA refuse Suzhou Win Health International Co.,Ltd.'s shipments?
- The most frequent charges are NDIDIETSP (ndidietsp, 4 lines) and UNSFDIETSP (dietary ingredient without safety assurance, 1 line).
- What is Suzhou Win Health International Co.,Ltd.'s FEI number?
- Suzhou Win Health International Co.,Ltd.'s FDA Establishment Identifier (FEI) is 3014097022.
- Can shipments from Suzhou Win Health International Co.,Ltd. still enter the U.S.?
- Shipments of higenamine from Suzhou Win Health International Co.,Ltd. can be detained without physical examination under Import Alert 54-18; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).
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