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Soim Nurwicaksono Boim

⚠️ Moderate Risk

FEI: 3012178269 • Pontianakpontianak • INDONESIA

FEI

FEI Number

3012178269

📍

Location

Pontianakpontianak

🇮🇩

Country

INDONESIA
🏢

Address

Jl. Sutan Hamid Rt 002/Rw 22 Siantan, , Pontianakpontianak, , Indonesia

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
3
Unique Violations
8/12/2016
Latest Refusal
8/12/2016
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

21201×

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.

2181×

LIST INGRE

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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

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
8/12/2016
54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
218LIST INGRE
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Soim Nurwicaksono Boim's FDA import refusal history?

Soim Nurwicaksono Boim (FEI: 3012178269) has 1 FDA import refusal record(s) in our database, spanning from 8/12/2016 to 8/12/2016.

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. Soim Nurwicaksono Boim's FEI number is 3012178269.

What types of violations has Soim Nurwicaksono Boim received?

Soim Nurwicaksono Boim 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 Soim Nurwicaksono Boim come from?

All FDA import refusal data for Soim Nurwicaksono Boim 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.