SORIA NATURAL S.A.
⚠️ Moderate Risk
FEI: 3003703696 • Garray, Soria • SPAIN
FEI Number
3003703696
Location
Garray, Soria
Country
SPAINAddress
Camino Saceda NR. 1, , Garray, Soria, Spain
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
DIETARY
The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.
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).
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/20/2013 | 41ECY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE) | 2300DIETARYLBL | San Juan District Office (SJN-DO) |
| 8/20/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 8/20/2013 | 41ECY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE) | 262DIETARY | San Juan District Office (SJN-DO) |
| 8/20/2013 | 41ECY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE) | 262DIETARY | San Juan District Office (SJN-DO) |
| 8/20/2013 | 41ECY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE) | 262DIETARY | San Juan District Office (SJN-DO) |
| 8/20/2013 | 41ECY99MEAL REPLACEMENTS (NOT LABELED FOR TREATMENT OF DISEASE) | 262DIETARY | San Juan District Office (SJN-DO) |
| 9/16/2009 | 54YBL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 9/16/2009 | 54YBL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 262DIETARY | Los Angeles District Office (LOS-DO) |
| 12/29/2005 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/29/2005 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/29/2005 | 54FBL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/24/2004 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/24/2004 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is SORIA NATURAL S.A.'s FDA import refusal history?
SORIA NATURAL S.A. (FEI: 3003703696) has 13 FDA import refusal record(s) in our database, spanning from 5/24/2004 to 8/20/2013.
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. SORIA NATURAL S.A.'s FEI number is 3003703696.
What types of violations has SORIA NATURAL S.A. received?
SORIA NATURAL S.A. has been cited for 5 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 SORIA NATURAL S.A. come from?
All FDA import refusal data for SORIA NATURAL S.A. 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.