Produits Dave Hampton
⚠️ Moderate Risk
FEI: 3003185618 • Mirabel, Quebec • CANADA
FEI Number
3003185618
Location
Mirabel, Quebec
Country
CANADAAddress
105-14056 Rte 117, , Mirabel, Quebec, Canada
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
HELD INSAN
The cosmetic appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/30/2006 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | Cincinnati District Office (CIN-DO) | |
| 10/29/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 313HELD INSAN | New York District Office (NYK-DO) |
| 10/29/2003 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 313HELD INSAN | New York District Office (NYK-DO) |
| 10/29/2003 | 53RC12SKIN CARE PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (BOVINE) | 313HELD INSAN | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Produits Dave Hampton's FDA import refusal history?
Produits Dave Hampton (FEI: 3003185618) has 4 FDA import refusal record(s) in our database, spanning from 10/29/2003 to 6/30/2006.
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. Produits Dave Hampton's FEI number is 3003185618.
What types of violations has Produits Dave Hampton received?
Produits Dave Hampton 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 Produits Dave Hampton come from?
All FDA import refusal data for Produits Dave Hampton 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.