Laboratoires Prodene Klint
⚠️ Moderate Risk
FEI: 3004353796 • Marne-La-Vallee, Seine-et-Marne • FRANCE
FEI Number
3004353796
Location
Marne-La-Vallee, Seine-et-Marne
Country
FRANCEAddress
8 Rue Leon Jouhaux, Croissy-Beaubourg, Marne-La-Vallee, Seine-et-Marne, France
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 |
|---|---|---|---|
| 11/2/2006 | 61HAL99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 4/18/2006 | 61HAL99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 1/23/2006 | 64ABL99DISINFECTANT N.E.C. | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 1/23/2006 | 64ABL99DISINFECTANT N.E.C. | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 10/6/2004 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 10/6/2004 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 10/6/2004 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Laboratoires Prodene Klint's FDA import refusal history?
Laboratoires Prodene Klint (FEI: 3004353796) has 7 FDA import refusal record(s) in our database, spanning from 10/6/2004 to 11/2/2006.
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. Laboratoires Prodene Klint's FEI number is 3004353796.
What types of violations has Laboratoires Prodene Klint received?
Laboratoires Prodene Klint 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 Laboratoires Prodene Klint come from?
All FDA import refusal data for Laboratoires Prodene Klint 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.