JNTL Consumer Health (France) SAS
⚠️ Moderate Risk
FEI: 3002707994 • Val De Reuil • FRANCE
FEI Number
3002707994
Location
Val De Reuil
Country
FRANCEAddress
Domaine De Maigremont, , Val De Reuil, , 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
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).
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/13/2020 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2019 | 60CAE09PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/7/2019 | 60CAE09PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/27/2010 | 66YBJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New England District Office (NWE-DO) |
Frequently Asked Questions
What is JNTL Consumer Health (France) SAS's FDA import refusal history?
JNTL Consumer Health (France) SAS (FEI: 3002707994) has 4 FDA import refusal record(s) in our database, spanning from 8/27/2010 to 1/13/2020.
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. JNTL Consumer Health (France) SAS's FEI number is 3002707994.
What types of violations has JNTL Consumer Health (France) SAS received?
JNTL Consumer Health (France) SAS 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 JNTL Consumer Health (France) SAS come from?
All FDA import refusal data for JNTL Consumer Health (France) SAS 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.