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Flowbee International

⚠️ Moderate Risk

FEI: 3003417082 • Hagatna, GU • UNITED STATES

FEI

FEI Number

3003417082

📍

Location

Hagatna, GU

🇺🇸
🏢

Address

288 Obrien Drive, , Hagatna, GU, United States

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
10/10/2001
Latest Refusal
10/10/2001
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
10/10/2001
54FAT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
10/10/2001
54FBY48GINKGO BILOBA (HERBAL & BOTANICALS, NOT TEAS)
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Flowbee International's FDA import refusal history?

Flowbee International (FEI: 3003417082) has 2 FDA import refusal record(s) in our database, spanning from 10/10/2001 to 10/10/2001.

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. Flowbee International's FEI number is 3003417082.

What types of violations has Flowbee International received?

Flowbee International 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 Flowbee International come from?

All FDA import refusal data for Flowbee International 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.