Laboratorios Argenol, S.L.
✅ Low Risk
FEI: 3002807434 • Zaragoza, Zaragoza • SPAIN
FEI Number
3002807434
Location
Zaragoza, Zaragoza
Country
SPAINAddress
Poligono Industrial Europa 1, Ii, Zaragoza, Zaragoza, Spain
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 4/21/2009 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Minneapolis District Office (MIN-DO) | |
| 10/8/2002 | 62FDZ38SILVER SULFADIAZINE (ANTI-INFECTIVE, TOPICAL) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Laboratorios Argenol, S.L.'s FDA import refusal history?
Laboratorios Argenol, S.L. (FEI: 3002807434) has 2 FDA import refusal record(s) in our database, spanning from 10/8/2002 to 4/21/2009.
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 Argenol, S.L.'s FEI number is 3002807434.
What types of violations has Laboratorios Argenol, S.L. received?
Laboratorios Argenol, S.L. 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 Argenol, S.L. come from?
All FDA import refusal data for Laboratorios Argenol, S.L. 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.