Yuxing Biotechnology (Group) Co., Ltd.
⚠️ High Risk
FEI: 3008996626 • Xingtai, Hebei • CHINA
FEI Number
3008996626
Location
Xingtai, Hebei
Country
CHINAAddress
Xicheng District, Ningjin County, Xingtai, Hebei, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
SUPPL GMP
The article appears to be a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/23/2024 | 54ACY05VITAMIN B12 (CYANOCOBALAMIN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/26/2023 | 54ABT10MECOBALAMIN (VITAMIN) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 6/26/2023 | 54ABT10MECOBALAMIN (VITAMIN) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 6/26/2023 | 54ABT10MECOBALAMIN (VITAMIN) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 6/26/2023 | 54ABT10MECOBALAMIN (VITAMIN) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 6/26/2023 | 54ABT05VITAMIN B12 (CYANOCOBALAMIN) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 6/26/2023 | 54ABT05VITAMIN B12 (CYANOCOBALAMIN) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 6/26/2023 | 54ABT05VITAMIN B12 (CYANOCOBALAMIN) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 6/26/2023 | 54ABT05VITAMIN B12 (CYANOCOBALAMIN) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 3/15/2023 | 54ABY11HYDROXOCOBALAMIN (VITAMIN) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 3/13/2023 | 54ABY10MECOBALAMIN (VITAMIN) | 3560SUPPL GMP | Division of Northern Border Imports (DNBI) |
| 1/17/2023 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 9/25/2019 | 54ABR10MECOBALAMIN (VITAMIN) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 4/2/2019 | 54ABY10MECOBALAMIN (VITAMIN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/27/2017 | 54AYR11HYDROXOCOBALAMIN (VITAMIN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Yuxing Biotechnology (Group) Co., Ltd.'s FDA import refusal history?
Yuxing Biotechnology (Group) Co., Ltd. (FEI: 3008996626) has 15 FDA import refusal record(s) in our database, spanning from 6/27/2017 to 2/23/2024.
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. Yuxing Biotechnology (Group) Co., Ltd.'s FEI number is 3008996626.
What types of violations has Yuxing Biotechnology (Group) Co., Ltd. received?
Yuxing Biotechnology (Group) Co., Ltd. has been cited for 3 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 Yuxing Biotechnology (Group) Co., Ltd. come from?
All FDA import refusal data for Yuxing Biotechnology (Group) 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.