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GOANG YUAN COMPANY LIMITED

⚠️ Moderate Risk

FEI: 3004656777 • TAI-BAO, TW-CYI • TAIWAN

FEI

FEI Number

3004656777

📍

Location

TAI-BAO, TW-CYI

🇹🇼

Country

TAIWAN
🏢

Address

23-1 MAPLE LANE, , TAI-BAO, TW-CYI, Taiwan

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
8/19/2010
Latest Refusal
8/19/2010
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

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

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
8/19/2010
21HGT14PLUM, DRIED OR PASTE
260FALSE
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is GOANG YUAN COMPANY LIMITED's FDA import refusal history?

GOANG YUAN COMPANY LIMITED (FEI: 3004656777) has 1 FDA import refusal record(s) in our database, spanning from 8/19/2010 to 8/19/2010.

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. GOANG YUAN COMPANY LIMITED's FEI number is 3004656777.

What types of violations has GOANG YUAN COMPANY LIMITED received?

GOANG YUAN COMPANY LIMITED 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 GOANG YUAN COMPANY LIMITED come from?

All FDA import refusal data for GOANG YUAN COMPANY LIMITED 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.