F.H.P. Motor-Cross S.C.
⚠️ Moderate Risk
FEI: 3004891835 • Siedliska, Malopolskie • POLAND
FEI Number
3004891835
Location
Siedliska, Malopolskie
Country
POLANDAddress
Siedliska 6a, , Siedliska, Malopolskie, Poland
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
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 |
|---|---|---|---|
| 5/10/2006 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 5/10/2006 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 5/10/2006 | 66PDL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is F.H.P. Motor-Cross S.C.'s FDA import refusal history?
F.H.P. Motor-Cross S.C. (FEI: 3004891835) has 3 FDA import refusal record(s) in our database, spanning from 5/10/2006 to 5/10/2006.
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. F.H.P. Motor-Cross S.C.'s FEI number is 3004891835.
What types of violations has F.H.P. Motor-Cross S.C. received?
F.H.P. Motor-Cross S.C. 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 F.H.P. Motor-Cross S.C. come from?
All FDA import refusal data for F.H.P. Motor-Cross S.C. 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.