Activa SARL
⚠️ Moderate Risk
FEI: 2000017378 • Paris, Paris • FRANCE
FEI Number
2000017378
Location
Paris, Paris
Country
FRANCEAddress
49 rue de Ponthieu, , Paris, Paris, 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
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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).
NCONTACTS
The product is a dietary supplement that is marketed in the United States and appears to not have a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/28/2013 | 54YBE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3681NCONTACTS | New Orleans District Office (NOL-DO) |
| 5/28/2013 | 54BYE99MINERAL N.E.C. | 3681NCONTACTS | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/26/2011 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Activa SARL's FDA import refusal history?
Activa SARL (FEI: 2000017378) has 22 FDA import refusal record(s) in our database, spanning from 7/26/2011 to 5/28/2013.
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. Activa SARL's FEI number is 2000017378.
What types of violations has Activa SARL received?
Activa SARL has been cited for 3 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 Activa SARL come from?
All FDA import refusal data for Activa SARL 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.