laboratorios tegor
⚠️ High Risk
FEI: 3015182956 • Zamudio, Vizcaya • SPAIN
FEI Number
3015182956
Location
Zamudio, Vizcaya
Country
SPAINAddress
Poligono Industrial Ugaldeguren 1, , Zamudio, Vizcaya, Spain
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/2/2015 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 474COSMETLBLG | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 474COSMETLBLG | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 474COSMETLBLG | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 474COSMETLBLG | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/2/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/2/2015 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 12/2/2015 | 53GD06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53GD06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53GD06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53GD06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53GD06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53GD06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53GD06MAKEUP BASES (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53GC08MAKEUP FIXATIVES (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LD08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53GC08MAKEUP FIXATIVES (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53GC08MAKEUP FIXATIVES (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53CD04EYE LOTION (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 12/2/2015 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/2/2015 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/2/2015 | 53CD04EYE LOTION (EYE MAKEUP PREPARATIONS) | 11UNSAFE COL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is laboratorios tegor's FDA import refusal history?
laboratorios tegor (FEI: 3015182956) has 32 FDA import refusal record(s) in our database, spanning from 12/2/2015 to 12/2/2015.
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. laboratorios tegor's FEI number is 3015182956.
What types of violations has laboratorios tegor received?
laboratorios tegor 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 laboratorios tegor come from?
All FDA import refusal data for laboratorios tegor 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.