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Xing Da Herbal Processing Factory

⚠️ Moderate Risk

FEI: 3004249848 • Tianjin, Beijingshi • CHINA

FEI

FEI Number

3004249848

📍

Location

Tianjin, Beijingshi

🇨🇳

Country

CHINA
🏢

Address

No. 1, Ke Yuan Rd., Bei Chen Technology, District, Tianjin, Beijingshi, China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
5/19/2005
Latest Refusal
5/19/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

1181×

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
5/19/2005
66VBA99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Xing Da Herbal Processing Factory's FDA import refusal history?

Xing Da Herbal Processing Factory (FEI: 3004249848) has 1 FDA import refusal record(s) in our database, spanning from 5/19/2005 to 5/19/2005.

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. Xing Da Herbal Processing Factory's FEI number is 3004249848.

What types of violations has Xing Da Herbal Processing Factory received?

Xing Da Herbal Processing Factory 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 Xing Da Herbal Processing Factory come from?

All FDA import refusal data for Xing Da Herbal Processing Factory 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.