Laboratorios Genove
⚠️ Moderate Risk
FEI: 3011912500 • Barcelona, Barcelona • SPAIN
FEI Number
3011912500
Location
Barcelona, Barcelona
Country
SPAINAddress
Passatge del Carrilet , 293, Hospitalet, , Barcelona, Barcelona, 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
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).
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/20/2023 | 54FDE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/7/2023 | 54YYB99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/17/2023 | 54ABY99VITAMIN, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2023 | 54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Laboratorios Genove's FDA import refusal history?
Laboratorios Genove (FEI: 3011912500) has 4 FDA import refusal record(s) in our database, spanning from 1/3/2023 to 7/20/2023.
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 Genove's FEI number is 3011912500.
What types of violations has Laboratorios Genove received?
Laboratorios Genove 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 Laboratorios Genove come from?
All FDA import refusal data for Laboratorios Genove 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.