Allen Preston
⚠️ Moderate Risk
FEI: 3006157955 • Oslo • NORWAY
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/30/2007 | 61PCB99ANTI-DIABETIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/30/2007 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/30/2007 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/30/2007 | 61NCA71LITHIUM CITRATE (ANTI-DEPRESSANT) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/30/2007 | 63EDA99CARDIAC DEPRESSANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Allen Preston's FDA import refusal history?
Allen Preston (FEI: 3006157955) has 5 FDA import refusal record(s) in our database, spanning from 3/30/2007 to 3/30/2007.
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. Allen Preston's FEI number is 3006157955.
What types of violations has Allen Preston received?
Allen Preston has been cited for 1 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 Allen Preston come from?
All FDA import refusal data for Allen Preston 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.