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GFCO Biotechnology Products Corp.

⚠️ Moderate Risk

FEI: 3006305447 • Taipei City, Taipei - Special Municipality • TAIWAN

FEI

FEI Number

3006305447

📍

Location

Taipei City, Taipei - Special Municipality

🇹🇼

Country

TAIWAN
🏢

Address

9 Fl., Zhongshan Dist., Taipei City, Taipei - Special Municipality, Taiwan

Moderate Risk

FDA Import Risk Assessment

31.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
2/6/2008
Latest Refusal
2/6/2008
Earliest Refusal

Score Breakdown

Violation Severity
66.7×40%
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

2621×

DIETARY

The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.

4881×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

831×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
2/6/2008
30YCE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
262DIETARY
488HEALTH C
83NO PROCESS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is GFCO Biotechnology Products Corp.'s FDA import refusal history?

GFCO Biotechnology Products Corp. (FEI: 3006305447) has 1 FDA import refusal record(s) in our database, spanning from 2/6/2008 to 2/6/2008.

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. GFCO Biotechnology Products Corp.'s FEI number is 3006305447.

What types of violations has GFCO Biotechnology Products Corp. received?

GFCO Biotechnology Products Corp. 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 GFCO Biotechnology Products Corp. come from?

All FDA import refusal data for GFCO Biotechnology Products Corp. 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.