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CV. SETIA COCONUT INDONESIA

⚠️ Moderate Risk

FEI: 3017617232 • Kota Singkawang Kalim • INDONESIA

FEI

FEI Number

3017617232

📍

Location

Kota Singkawang Kalim

🇮🇩

Country

INDONESIA
🏢

Address

Rt. 0, Jl. Kaliasin Luar, Kota Singkawang Kalim, , Indonesia

Moderate Risk

FDA Import Risk Assessment

44.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
3/21/2022
Latest Refusal
3/10/2021
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
23.8×20%
Frequency
19.4×10%
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.

39001×

NDIDIETSP

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be a food that is a dietary supplement or that contains a dietary ingredient that is a new dietary 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.

Refusal History

DateProductViolationsDivision
3/21/2022
54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
3900NDIDIETSP
Division of Northeast Imports (DNEI)
3/10/2021
53LH08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
2120UNSFDIETSP
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is CV. SETIA COCONUT INDONESIA's FDA import refusal history?

CV. SETIA COCONUT INDONESIA (FEI: 3017617232) has 2 FDA import refusal record(s) in our database, spanning from 3/10/2021 to 3/21/2022.

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. CV. SETIA COCONUT INDONESIA's FEI number is 3017617232.

What types of violations has CV. SETIA COCONUT INDONESIA received?

CV. SETIA COCONUT INDONESIA 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 CV. SETIA COCONUT INDONESIA come from?

All FDA import refusal data for CV. SETIA COCONUT INDONESIA 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.