Sichuan Sentaiyuan Biotechnology Co.,Ltd
⚠️ Moderate Risk
FEI: 3011405960 • Leshan, Sichuan • CHINA
FEI Number
3011405960
Location
Leshan, Sichuan
Country
CHINAAddress
2 Fenghuangcun, Jianhexiang Muchuanxian, Leshan, Sichuan, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
USUAL NAME
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/21/2015 | 04CGT07NOODLES, INSTANT | Los Angeles District Office (LOS-DO) | |
| 7/21/2015 | 04CGT07NOODLES, INSTANT | Los Angeles District Office (LOS-DO) | |
| 7/21/2015 | 04CGT07NOODLES, INSTANT | Los Angeles District Office (LOS-DO) | |
| 7/21/2015 | 04YGT99MACARONI/NOODLE PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 7/21/2015 | 04YGT99MACARONI/NOODLE PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 7/21/2015 | 04YGT99MACARONI/NOODLE PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 7/21/2015 | 04YGT99MACARONI/NOODLE PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 7/21/2015 | 25JGT32KONJAC (ROOT & TUBER VEGETABLE) | Los Angeles District Office (LOS-DO) | |
| 7/21/2015 | 04YGT99MACARONI/NOODLE PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sichuan Sentaiyuan Biotechnology Co.,Ltd's FDA import refusal history?
Sichuan Sentaiyuan Biotechnology Co.,Ltd (FEI: 3011405960) has 9 FDA import refusal record(s) in our database, spanning from 7/21/2015 to 7/21/2015.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Sichuan Sentaiyuan Biotechnology Co.,Ltd's FEI number is 3011405960.
What types of violations has Sichuan Sentaiyuan Biotechnology Co.,Ltd received?
Sichuan Sentaiyuan Biotechnology Co.,Ltd has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Sichuan Sentaiyuan Biotechnology Co.,Ltd come from?
All FDA import refusal data for Sichuan Sentaiyuan Biotechnology Co.,Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.