KALASAN NIRWANA, CV
⚠️ Moderate Risk
FEI: 3013655855 • Bogor, Jabotabek • INDONESIA
FEI Number
3013655855
Location
Bogor, Jabotabek
Country
INDONESIAAddress
Grand Sentul Blok B3/5no 6 Bogor, , Bogor, Jabotabek, 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.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/23/2017 | 54JYR12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 8/23/2017 | 54JYR12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 8/3/2017 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Division of Northern Border Imports (DNBI) | |
| 7/17/2017 | 54JYY12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is KALASAN NIRWANA, CV's FDA import refusal history?
KALASAN NIRWANA, CV (FEI: 3013655855) has 4 FDA import refusal record(s) in our database, spanning from 7/17/2017 to 8/23/2017.
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. KALASAN NIRWANA, CV's FEI number is 3013655855.
What types of violations has KALASAN NIRWANA, CV received?
KALASAN NIRWANA, CV 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 KALASAN NIRWANA, CV come from?
All FDA import refusal data for KALASAN NIRWANA, CV 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.