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Rudi Hartona

⚠️ High Risk

FEI: 3011337990 • Pontianak, Kalimantan Barat • INDONESIA

FEI

FEI Number

3011337990

📍

Location

Pontianak, Kalimantan Barat

🇮🇩

Country

INDONESIA
🏢

Address

Jln. Tanjung Harapan, , Pontianak, Kalimantan Barat, Indonesia

High Risk

FDA Import Risk Assessment

56.9
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

19
Total Refusals
3
Unique Violations
10/26/2015
Latest Refusal
3/10/2015
Earliest Refusal

Score Breakdown

Violation Severity
81.0×40%
Refusal Volume
48.2×30%
Recency
0.0×20%
Frequency
100.0×10%
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

212018×

UNSFDIETSP

The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

31201×

EPHEDALK

The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.

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
10/26/2015
53PH99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
10/16/2015
53PH99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
Division of Southeast Imports (DSEI)
10/8/2015
54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
3120EPHEDALK
New Orleans District Office (NOL-DO)
10/8/2015
53PH99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
10/8/2015
53PH99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
10/8/2015
53PH99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
10/8/2015
53PH99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
10/8/2015
53PH99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
10/8/2015
53PH99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
10/8/2015
53PH99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
10/8/2015
53PH99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
10/8/2015
53PH99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
10/8/2015
54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
Division of Southeast Imports (DSEI)
10/8/2015
54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
10/8/2015
54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
10/8/2015
54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
10/8/2015
54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
10/8/2015
53PH99OTHER COSMETIC RAW MATERIALS, N.E.C.
2120UNSFDIETSP
New Orleans District Office (NOL-DO)
3/10/2015
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2120UNSFDIETSP
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Rudi Hartona's FDA import refusal history?

Rudi Hartona (FEI: 3011337990) has 19 FDA import refusal record(s) in our database, spanning from 3/10/2015 to 10/26/2015.

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. Rudi Hartona's FEI number is 3011337990.

What types of violations has Rudi Hartona received?

Rudi Hartona 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 Rudi Hartona come from?

All FDA import refusal data for Rudi Hartona 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.