Pt Rifa Agung
⚠️ High Risk
FEI: 3011506661 • Pontianak, Kalimantan Barat • INDONESIA
FEI Number
3011506661
Location
Pontianak, Kalimantan Barat
Country
INDONESIAAddress
09 Jln. Mat Saimin, , Pontianak, Kalimantan Barat, Indonesia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2016 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/22/2015 | 53PH99OTHER COSMETIC RAW MATERIALS, N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 10/22/2015 | 53PH99OTHER COSMETIC RAW MATERIALS, N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 10/21/2015 | 54Y99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 10/16/2015 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 8/14/2015 | 53P99OTHER COSMETIC RAW MATERIALS, N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 8/14/2015 | 53P99OTHER COSMETIC RAW MATERIALS, N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 8/12/2015 | 54EYY99HERBALS & BOTANICAL TEAS, N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 8/6/2015 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 8/6/2015 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Pt Rifa Agung's FDA import refusal history?
Pt Rifa Agung (FEI: 3011506661) has 10 FDA import refusal record(s) in our database, spanning from 8/6/2015 to 1/7/2016.
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. Pt Rifa Agung's FEI number is 3011506661.
What types of violations has Pt Rifa Agung received?
Pt Rifa Agung 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 Pt Rifa Agung come from?
All FDA import refusal data for Pt Rifa Agung 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.