XI AN AOGU BIOTECH CO LTD
⚠️ High Risk
FEI: 3020188413 • Xian, Shanxi • CHINA
FEI Number
3020188413
Location
Xian, Shanxi
Country
CHINAAddress
Block B Room 606, 3 Jinye Road; Yanta, Xian, Shanxi, 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
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 11/10/2025 | 54FCY93NONI (HERBAL & BOTANICALS, NOT TEAS) | Division of Southeast Imports (DSEI) | |
| 4/19/2024 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 238UNSAFE ADD | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is XI AN AOGU BIOTECH CO LTD's FDA import refusal history?
XI AN AOGU BIOTECH CO LTD (FEI: 3020188413) has 2 FDA import refusal record(s) in our database, spanning from 4/19/2024 to 11/10/2025.
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. XI AN AOGU BIOTECH CO LTD's FEI number is 3020188413.
What types of violations has XI AN AOGU BIOTECH CO LTD received?
XI AN AOGU BIOTECH 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 XI AN AOGU BIOTECH CO LTD come from?
All FDA import refusal data for XI AN AOGU BIOTECH 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.