Fadilindo Jasa Antaran
⚠️ Moderate Risk
FEI: 3011653822 • Bekasi, Jabotabek • INDONESIA
FEI Number
3011653822
Location
Bekasi, Jabotabek
Country
INDONESIAAddress
Jl Andini Sakti No51 Rt02/7 Cibitung, , Bekasi, 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
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.
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.
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
UNSAFE SUB
The article appears to bear or contain a substance which is unsafe within the meaning of Section 406.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/16/2018 | 54KCS12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 4/16/2018 | 54KCR12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 4/4/2016 | 54JBR12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED) | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 1/4/2016 | 54FYR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 280UNSAFE SUB | Los Angeles District Office (LOS-DO) |
| 12/3/2015 | 53PH99OTHER COSMETIC RAW MATERIALS, N.E.C. | 2460UNSFDIETLB | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Fadilindo Jasa Antaran's FDA import refusal history?
Fadilindo Jasa Antaran (FEI: 3011653822) has 5 FDA import refusal record(s) in our database, spanning from 12/3/2015 to 4/16/2018.
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. Fadilindo Jasa Antaran's FEI number is 3011653822.
What types of violations has Fadilindo Jasa Antaran received?
Fadilindo Jasa Antaran 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 Fadilindo Jasa Antaran come from?
All FDA import refusal data for Fadilindo Jasa Antaran 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.