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Xi'An Fujie Bio-Tech Co., Ltd

⚠️ Moderate Risk

FEI: 3004568387 • Xian, Shanxi • CHINA

FEI

FEI Number

3004568387

📍

Location

Xian, Shanxi

🇨🇳

Country

CHINA
🏢

Address

No 258 Huanyuan Middle Rd, Weiyang, Xian, Shanxi, China

Moderate Risk

FDA Import Risk Assessment

41.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
2
Unique Violations
1/25/2005
Latest Refusal
11/17/2004
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1221×

ANTIBIOTIC

The drug appears to purport, or represented as, being composed wholly or partly of an antibiotic and it does not appear to be from a batch with respect to which a certificate or release has been issued pursuant to section 507. REPEALED11/97

2491×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

Refusal History

DateProductViolationsDivision
1/25/2005
25SGH01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C.
249FILTHY
Los Angeles District Office (LOS-DO)
11/17/2004
56YAR99ANTIBIOTIC N.E.C.
122ANTIBIOTIC
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Xi'An Fujie Bio-Tech Co., Ltd's FDA import refusal history?

Xi'An Fujie Bio-Tech Co., Ltd (FEI: 3004568387) has 2 FDA import refusal record(s) in our database, spanning from 11/17/2004 to 1/25/2005.

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 Fujie Bio-Tech Co., Ltd's FEI number is 3004568387.

What types of violations has Xi'An Fujie Bio-Tech Co., Ltd received?

Xi'An Fujie Bio-Tech Co., Ltd has been cited for 2 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 Fujie Bio-Tech Co., Ltd come from?

All FDA import refusal data for Xi'An Fujie Bio-Tech 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.