ORBE, S.A.
⚠️ Moderate Risk
FEI: 3013022970 • Vigo, Pontevedra • SPAIN
FEI Number
3013022970
Location
Vigo, Pontevedra
Country
SPAINAddress
Calle De Tomas A Alonso 106, , Vigo, Pontevedra, 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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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.
WRONG IDEN
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 as defined in section 403(b) of the FD&C Act. The article appears to be offered for sale under the name of another food.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/15/2017 | 16MEE09OCTOPUS, OTHER AQUATIC SPECIES | 260FALSE | Division of Southeast Imports (DSEI) |
| 5/2/2017 | 16MEE09OCTOPUS, OTHER AQUATIC SPECIES | 319WRONG IDEN | Division of Southeast Imports (DSEI) |
| 5/2/2017 | 16MEE09OCTOPUS, OTHER AQUATIC SPECIES | 319WRONG IDEN | Division of Southeast Imports (DSEI) |
| 5/2/2017 | 16MEE09OCTOPUS, OTHER AQUATIC SPECIES | 319WRONG IDEN | Division of Southeast Imports (DSEI) |
| 5/2/2017 | 16MEE09OCTOPUS, OTHER AQUATIC SPECIES | 260FALSE | Division of Southeast Imports (DSEI) |
| 5/2/2017 | 16MEE09OCTOPUS, OTHER AQUATIC SPECIES | 260FALSE | Division of Southeast Imports (DSEI) |
| 5/2/2017 | 16MEE09OCTOPUS, OTHER AQUATIC SPECIES | 260FALSE | Division of Southeast Imports (DSEI) |
| 5/9/2006 | 16AEE01ANCHOVY | 482NUTRIT LBL | Los Angeles District Office (LOS-DO) |
| 6/22/2003 | 16SEE45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.), COLD SMOKED, FISH | 83NO PROCESS | New York District Office (NYK-DO) |
| 4/7/2003 | 16AEE45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 4/7/2003 | 16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 3/19/2003 | 16AEE01ANCHOVY | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 3/19/2003 | 16AEE01ANCHOVY | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 7/10/2002 | 16MEE03SQUID, OTHER AQUATIC SPECIES | Detroit District Office (DET-DO) | |
| 7/10/2002 | 16MEE09OCTOPUS, OTHER AQUATIC SPECIES | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is ORBE, S.A.'s FDA import refusal history?
ORBE, S.A. (FEI: 3013022970) has 15 FDA import refusal record(s) in our database, spanning from 7/10/2002 to 5/15/2017.
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. ORBE, S.A.'s FEI number is 3013022970.
What types of violations has ORBE, S.A. received?
ORBE, 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 ORBE, S.A. come from?
All FDA import refusal data for ORBE, 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.