Pt. Sentosa Herbal Indonesia
⚠️ Moderate Risk
FEI: 3015624780 • Pontianak, Kalimantan Barat • INDONESIA
FEI Number
3015624780
Location
Pontianak, Kalimantan Barat
Country
INDONESIAAddress
Jln. Karya Baru, Komp. Pondok Pelangi A2 No. 1 Parit Tokaya; Selatan, Pontianak, Kalimantan Barat, Indonesia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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.
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/28/2022 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Division of Northeast Imports (DNEI) | |
| 6/15/2021 | 54KYY12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 3900NDIDIETSP | Division of Southeast Imports (DSEI) |
| 12/17/2020 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 12/2/2020 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Northeast Imports (DNEI) |
| 7/30/2020 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of West Coast Imports (DWCI) |
| 7/30/2020 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Pt. Sentosa Herbal Indonesia's FDA import refusal history?
Pt. Sentosa Herbal Indonesia (FEI: 3015624780) has 6 FDA import refusal record(s) in our database, spanning from 7/30/2020 to 2/28/2022.
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. Pt. Sentosa Herbal Indonesia's FEI number is 3015624780.
What types of violations has Pt. Sentosa Herbal Indonesia received?
Pt. Sentosa Herbal Indonesia has been cited for 5 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 Pt. Sentosa Herbal Indonesia come from?
All FDA import refusal data for Pt. Sentosa Herbal 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.