Irvan Januardi
⚠️ Moderate Risk
FEI: 3011906671 • Pontianakpontianak • INDONESIA
FEI Number
3011906671
Location
Pontianakpontianak
Country
INDONESIAAddress
Jln. Kom Yos Sudarso No 46 Gg. Kelapa 3, , Pontianakpontianak, , 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.
UNSFDIETUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a dietary supplement or contain a dietary ingredient that renders it adulterated under section 402(a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/9/2019 | 54JYY12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 5/23/2018 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 5/23/2018 | 54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 7/7/2016 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 7/6/2016 | 54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 6/30/2016 | 54KFS12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 5/13/2016 | 54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2461UNSFDIETUS | Cincinnati District Office (CIN-DO) |
| 5/13/2016 | 54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2461UNSFDIETUS | Cincinnati District Office (CIN-DO) |
| 4/29/2016 | 54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 1/28/2016 | 54F99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 1/21/2016 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Irvan Januardi's FDA import refusal history?
Irvan Januardi (FEI: 3011906671) has 11 FDA import refusal record(s) in our database, spanning from 1/21/2016 to 1/9/2019.
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. Irvan Januardi's FEI number is 3011906671.
What types of violations has Irvan Januardi received?
Irvan Januardi 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 Irvan Januardi come from?
All FDA import refusal data for Irvan Januardi 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.