ULTRA LABORATORIOS
⚠️ High Risk
FEI: 3012455152 • Guadalajara, Jalisco • MEXICO
FEI Number
3012455152
Location
Guadalajara, Jalisco
Country
MEXICOAddress
Avenida Doctor R. Michel 2920, Col. MIRADOR ALAMO INDUSTRIAL, Guadalajara, Jalisco, 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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/18/2026 | 62KCA10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2025 | 62GCY49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2025 | 64BCY25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2025 | 66JCY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2025 | 62OCY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2025 | 58SCY15ETANERCEPT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2025 | 62LCY29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2025 | 64LCY56PREDNISONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2025 | 61GCY61SULFASALAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2025 | 62TDA06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 61WDE45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 62GCY59PIROXICAM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/6/2025 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/26/2024 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2023 | 62ODY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2023 | 62OCY20CAPTOPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2023 | 66RDY99VASOCONSTRICTOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2022 | 63ACA11IBANDRONATE SODIUM | Division of Southeast Imports (DSEI) | |
| 8/5/2021 | 65PCY02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/24/2021 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/19/2020 | 61WCY45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/9/2020 | 64LCY06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/10/2019 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/17/2019 | 65PDA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/5/2019 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2018 | 64BCA37SPIRONOLACTONE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2018 | 61JCA99ANTI-CHOLESTEREMIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2017 | 61ECY08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2017 | 64BCY25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/23/2017 | 62KAC10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2017 | 66RCB01ANGIOTENSIN AMIDE (VASOCONSTRICTOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/24/2017 | 61ECA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/28/2017 | 62KDY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/24/2017 | 62GCB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/10/2017 | 62KDY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/3/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2016 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2016 | 62ODA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2016 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2016 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/16/2016 | 62OCB29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is ULTRA LABORATORIOS's FDA import refusal history?
ULTRA LABORATORIOS (FEI: 3012455152) has 41 FDA import refusal record(s) in our database, spanning from 8/16/2016 to 1/18/2026.
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 LABORATORIOS's FEI number is 3012455152.
What types of violations has ULTRA LABORATORIOS received?
ULTRA LABORATORIOS 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 ULTRA LABORATORIOS come from?
All FDA import refusal data for ULTRA LABORATORIOS 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.