LABIALFARMA SA
⚠️ High Risk
FEI: 3038461662 • Ovoa, Viseu • PORTUGAL
FEI Number
3038461662
Location
Ovoa, Viseu
Country
PORTUGALAddress
Parque Industrial Das L, , Ovoa, Viseu, Portugal
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
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.
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 |
|---|---|---|---|
| 12/18/2025 | 54BCY03CHOLINE (MINERAL) | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 12/18/2025 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 260FALSE | Division of Southeast Imports (DSEI) |
| 12/18/2025 | 54BCL03CHOLINE (MINERAL) | 260FALSE | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 54BCY03CHOLINE (MINERAL) | 260FALSE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LABIALFARMA SA's FDA import refusal history?
LABIALFARMA SA (FEI: 3038461662) has 4 FDA import refusal record(s) in our database, spanning from 11/10/2025 to 12/18/2025.
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. LABIALFARMA SA's FEI number is 3038461662.
What types of violations has LABIALFARMA SA received?
LABIALFARMA SA has been cited for 2 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 LABIALFARMA SA come from?
All FDA import refusal data for LABIALFARMA SA 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.