ULTRA LABORATIOS SA DE CV
⚠️ High Risk
FEI: 3012550077 • Guadalajara • MEXICO
FEI Number
3012550077
Location
Guadalajara
Country
MEXICOAddress
Dr Roberto Michel 2920, , 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 |
|---|---|---|---|
| 9/19/2022 | 62OCY28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/17/2021 | 60LCY05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/17/2021 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2021 | 54ACA02VITAMIN B1 (THIAMINE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 61PCY11GLYBURIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 56JDA20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2019 | 62KDA10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2019 | 62GCA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/31/2019 | 62OCB41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/16/2018 | 62YCA07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2018 | 62OCB29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2018 | 55FY99CAPSULE SHELL, N.E.C., PHARM NECESSITY - CAPSULE SHELL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/2/2018 | 66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2017 | 61ECA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2017 | 62QCY07PHENYLBUTAZONE (ANTI-RHEUMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2017 | 61MCE99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2016 | 62OCA37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is ULTRA LABORATIOS SA DE CV's FDA import refusal history?
ULTRA LABORATIOS SA DE CV (FEI: 3012550077) has 17 FDA import refusal record(s) in our database, spanning from 10/5/2016 to 9/19/2022.
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 LABORATIOS SA DE CV's FEI number is 3012550077.
What types of violations has ULTRA LABORATIOS SA DE CV received?
ULTRA LABORATIOS SA DE CV 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 LABORATIOS SA DE CV come from?
All FDA import refusal data for ULTRA LABORATIOS SA DE CV 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.