Ultra Laboratories Sa
⚠️ Moderate Risk
FEI: 3006098002 • Guadalajaraguadalajara • MEXICO
FEI Number
3006098002
Location
Guadalajaraguadalajara
Country
MEXICOAddress
2920 Parque Ind El Alamo, , Guadalajaraguadalajara, , Mexico
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/23/2016 | 64CIA99EMETIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/26/2012 | 62KCY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/24/2007 | 62GDA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Ultra Laboratories Sa's FDA import refusal history?
Ultra Laboratories Sa (FEI: 3006098002) has 3 FDA import refusal record(s) in our database, spanning from 5/24/2007 to 6/23/2016.
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 Laboratories Sa's FEI number is 3006098002.
What types of violations has Ultra Laboratories Sa received?
Ultra Laboratories Sa 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 Laboratories Sa come from?
All FDA import refusal data for Ultra Laboratories 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.