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Shanghai Wanxiang Flavors & Fragrances Co.,Ltd.

⚠️ Moderate Risk

FEI: 3004269991 • Shanghai, CN-31 • CHINA

FEI

FEI Number

3004269991

📍

Location

Shanghai, CN-31

🇨🇳

Country

CHINA
🏢

Address

No. 4309 Hunan Road, Pudong, Shanghai, CN-31, China

Moderate Risk

FDA Import Risk Assessment

32.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/8/2006
Latest Refusal
8/4/2005
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

751×

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

DateProductViolationsDivision
4/8/2006
62MAS08MENTHOL (ANTI-PRURITIC)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
8/4/2005
62MAY08MENTHOL (ANTI-PRURITIC)
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Shanghai Wanxiang Flavors & Fragrances Co.,Ltd.'s FDA import refusal history?

Shanghai Wanxiang Flavors & Fragrances Co.,Ltd. (FEI: 3004269991) has 2 FDA import refusal record(s) in our database, spanning from 8/4/2005 to 4/8/2006.

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. Shanghai Wanxiang Flavors & Fragrances Co.,Ltd.'s FEI number is 3004269991.

What types of violations has Shanghai Wanxiang Flavors & Fragrances Co.,Ltd. received?

Shanghai Wanxiang Flavors & Fragrances 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 Shanghai Wanxiang Flavors & Fragrances Co.,Ltd. come from?

All FDA import refusal data for Shanghai Wanxiang Flavors & Fragrances 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.