PT. Angkutan Jasa Aviasi
⚠️ Moderate Risk
FEI: 3023289579 • Pontianak, Kalimantan Barat • INDONESIA
FEI Number
3023289579
Location
Pontianak, Kalimantan Barat
Country
INDONESIAAddress
Jln. Re. Martadinata No. 32, Gang Pala 1, 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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/4/2023 | 54KYT12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 12/4/2023 | 54KYT12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 4/24/2023 | 54KYT12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Division of Southeast Imports (DSEI) | |
| 10/27/2022 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is PT. Angkutan Jasa Aviasi's FDA import refusal history?
PT. Angkutan Jasa Aviasi (FEI: 3023289579) has 4 FDA import refusal record(s) in our database, spanning from 10/27/2022 to 12/4/2023.
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. Angkutan Jasa Aviasi's FEI number is 3023289579.
What types of violations has PT. Angkutan Jasa Aviasi received?
PT. Angkutan Jasa Aviasi has been cited for 4 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. Angkutan Jasa Aviasi come from?
All FDA import refusal data for PT. Angkutan Jasa Aviasi 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.