ULTRA LABORATORY
⚠️ High Risk
FEI: 3018259060 • Guadalajara • MEXICO
FEI Number
3018259060
Location
Guadalajara
Country
MEXICOAddress
Av. Dr. Roberto 44895, , Guadalajara, , Mexico
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
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 |
|---|---|---|---|
| 12/9/2025 | 62OCY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/1/2025 | 60LCY83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/13/2025 | 62TCA06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/3/2025 | 62KCH10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/22/2025 | 60LCA83CELECOXIB (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2024 | 64BDA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2024 | 62ODY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2024 | 62KCE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ULTRA LABORATORY's FDA import refusal history?
ULTRA LABORATORY (FEI: 3018259060) has 8 FDA import refusal record(s) in our database, spanning from 2/27/2024 to 12/9/2025.
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. ULTRA LABORATORY's FEI number is 3018259060.
What types of violations has ULTRA LABORATORY received?
ULTRA LABORATORY has been cited for 1 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 ULTRA LABORATORY come from?
All FDA import refusal data for ULTRA LABORATORY 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.