Sudarsono
⚠️ Moderate Risk
FEI: 3011909347 • Bekasibekasi • INDONESIA
FEI Number
3011909347
Location
Bekasibekasi
Country
INDONESIAAddress
Kampung Rawa Panjang Rt.03/03 Sepanjang, , Bekasibekasi, , 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.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/3/2016 | 53PH99OTHER COSMETIC RAW MATERIALS, N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 1/22/2016 | 54EBY99HERBALS & BOTANICAL TEAS, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 1/19/2016 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Sudarsono's FDA import refusal history?
Sudarsono (FEI: 3011909347) has 3 FDA import refusal record(s) in our database, spanning from 1/19/2016 to 2/3/2016.
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. Sudarsono's FEI number is 3011909347.
What types of violations has Sudarsono received?
Sudarsono 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 Sudarsono come from?
All FDA import refusal data for Sudarsono 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.