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Borneo Botanicals

⚠️ Moderate Risk

FEI: 3008389606 • Jawa Baratjawa Barat • INDONESIA

FEI

FEI Number

3008389606

📍

Location

Jawa Baratjawa Barat

🇮🇩

Country

INDONESIA
🏢

Address

Depok Jaya Agungji Melon Raya A4 No, , Jawa Baratjawa Barat, , Indonesia

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/12/2012
Latest Refusal
1/12/2012
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Refusal History

DateProductViolationsDivision
1/12/2012
66BCS99STIMULANT N.E.C.
16DIRECTIONS
336INCONSPICU
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Borneo Botanicals's FDA import refusal history?

Borneo Botanicals (FEI: 3008389606) has 1 FDA import refusal record(s) in our database, spanning from 1/12/2012 to 1/12/2012.

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. Borneo Botanicals's FEI number is 3008389606.

What types of violations has Borneo Botanicals received?

Borneo Botanicals 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 Borneo Botanicals come from?

All FDA import refusal data for Borneo Botanicals 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.