LABORATORIO ELEA PHOENIX SA
⚠️ Moderate Risk
FEI: 3016943651 • Los Polvorines • ARGENTINA
FEI Number
3016943651
Location
Los Polvorines
Country
ARGENTINAAddress
Av G J G Lemos 2809, , Los Polvorines, , Argentina
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
HEALTH C
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 bears an unauthorized nutrient content/health claim.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2025 | 54YBL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 1/7/2025 | 54YBL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 488HEALTH C | Division of Southeast Imports (DSEI) |
| 8/16/2021 | 65JCA31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LABORATORIO ELEA PHOENIX SA's FDA import refusal history?
LABORATORIO ELEA PHOENIX SA (FEI: 3016943651) has 3 FDA import refusal record(s) in our database, spanning from 8/16/2021 to 1/7/2025.
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. LABORATORIO ELEA PHOENIX SA's FEI number is 3016943651.
What types of violations has LABORATORIO ELEA PHOENIX SA received?
LABORATORIO ELEA PHOENIX 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 LABORATORIO ELEA PHOENIX SA come from?
All FDA import refusal data for LABORATORIO ELEA PHOENIX 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.