Ligne St. Barth SAS
⚠️ Moderate Risk
FEI: 3003233369 • St Barthelemy, Guadeloupe • FRANCE
FEI Number
3003233369
Location
St Barthelemy, Guadeloupe
Country
FRANCEAddress
Lorient, route de Saline, St Barthelemy, Guadeloupe, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
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).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/19/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 10/29/2013 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 10/29/2013 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 10/29/2013 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 10/29/2013 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 10/29/2013 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 10/29/2013 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 10/29/2013 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 10/29/2013 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 10/29/2013 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 10/29/2013 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 10/29/2013 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 10/29/2013 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/3/2013 | 66PAL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 11/1/2006 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 11/1/2006 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 1/4/2006 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 1/4/2006 | 66PBZ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Ligne St. Barth SAS's FDA import refusal history?
Ligne St. Barth SAS (FEI: 3003233369) has 18 FDA import refusal record(s) in our database, spanning from 1/4/2006 to 6/19/2014.
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. Ligne St. Barth SAS's FEI number is 3003233369.
What types of violations has Ligne St. Barth SAS received?
Ligne St. Barth 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 Ligne St. Barth SAS come from?
All FDA import refusal data for Ligne St. Barth 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.