CV. Arruls A2D
⚠️ Moderate Risk
FEI: 3012060999 • Pontianak, Kalimantan Barat • INDONESIA
FEI Number
3012060999
Location
Pontianak, Kalimantan Barat
Country
INDONESIAAddress
Jln. Purnama No. 39, , 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.
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 |
|---|---|---|---|
| 1/30/2018 | 54KBR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | Division of Southwest Imports (DSWI) | |
| 10/5/2016 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 10/5/2016 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 8/24/2016 | 54KCR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | New Orleans District Office (NOL-DO) |
| 8/8/2016 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 8/8/2016 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 6/24/2016 | 54KYR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is CV. Arruls A2D's FDA import refusal history?
CV. Arruls A2D (FEI: 3012060999) has 7 FDA import refusal record(s) in our database, spanning from 6/24/2016 to 1/30/2018.
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. Arruls A2D's FEI number is 3012060999.
What types of violations has CV. Arruls A2D received?
CV. Arruls A2D 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. Arruls A2D come from?
All FDA import refusal data for CV. Arruls A2D 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.