Xi'an Le Sen Bio-technology Co.,Ltd
FDA import alert and refusal historyXian, ChinaFEI 3013330700
As of October 26, 2026, Xi'an Le Sen Bio-technology Co.,Ltd (Xian, China) is on the red list of FDA Import Alert 54-18 (Supplements and ingredients with new dietary ingredients) for sakae naa, published by FDA on July 9, 2021, and has 4 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
- Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. · FRNMFGREG
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Xi'an Le Sen Bio-technology Co.,Ltd
5 records, newest first. Each line links to the FDA page it came from.
2021
- Import refusalRefused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.FRNMFGREGEntry 300-6945988-2Source
- Import alert listingListed on Import Alert 54-18red listSakae NAASource
- Import refusalRefused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNSFDIETSPEntry 300-4490970-4Source
2018
- Import refusalRefused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNSFDIETSPEntry AEK-4288480-6Source
2017
- Import refusalRefused, Dietary conventional foods, n.e.c.UNAPPROVEDEntry B8P-0085748-6Source
Refusal charges, in plain English
- UNSFDIETSP2 refused lines
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.
- FRNMFGREG1 refused line
FRNMFGREG
- UNAPPROVED1 refused line
Unapproved new drug
The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.
Questions about Xi'an Le Sen Bio-technology Co.,Ltd
- Is Xi'an Le Sen Bio-technology Co.,Ltd on an FDA import alert?
- Yes. As of October 26, 2026, Xi'an Le Sen Bio-technology Co.,Ltd is on the red list of FDA Import Alert 54-18, “Supplements and ingredients with new dietary ingredients”, for sakae naa; FDA published the listing on July 9, 2021.
- Has FDA refused shipments from Xi'an Le Sen Bio-technology Co.,Ltd?
- Yes. FDA refused 4 shipment lines from Xi'an Le Sen Bio-technology Co.,Ltd between August 22, 2017 and September 9, 2021. The most recent, on September 9, 2021, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as FRNMFGREG (frnmfgreg).
- Why did FDA refuse Xi'an Le Sen Bio-technology Co.,Ltd's shipments?
- The most frequent charges are UNSFDIETSP (dietary ingredient without safety assurance, 2 lines) and FRNMFGREG (frnmfgreg, 1 line).
- What is Xi'an Le Sen Bio-technology Co.,Ltd's FEI number?
- Xi'an Le Sen Bio-technology Co.,Ltd's FDA Establishment Identifier (FEI) is 3013330700.
- Can shipments from Xi'an Le Sen Bio-technology Co.,Ltd still enter the U.S.?
- Shipments of sakae naa from Xi'an Le Sen Bio-technology 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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