VICENTE ANTONIO ESCOBAR RESTREPO--
⚠️ High Risk
FEI: 3015149787 • Bogota • COLOMBIA
FEI
FEI Number
3015149787
📍
Location
Bogota
🇨🇴
Country
COLOMBIA🏢
Address
Calle 64g # 89a - 83, , Bogota, , Colombia
High Risk
FDA Import Risk Assessment
66.1
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
78
Total Refusals
2
Unique Violations
9/9/2020
Latest Refusal
3/11/2019
Earliest Refusal
Score Breakdown
Violation Severity
87.5×40%
Refusal Volume
70.3×30%
Recency
0.0×20%
Frequency
100.0×10%
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
7574×
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).
32805×
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 |
|---|---|---|---|
| 9/9/2020 | 63BCY26IPRATROPIUM BROMIDE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2020 | 63BCY01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/5/2020 | 62GCY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/5/2020 | 61MCY06CLONAZEPAM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/2/2020 | 61ECA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/2/2020 | 60ZDL15IVERMECTIN AND COMBINATIONS (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/2/2020 | 64GDY07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/28/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/28/2020 | 66NCA02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2020 | 60XDY02METOPROLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2020 | 65CDY04BETAINE ANHYDROUS (NUTRIENT/TONIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2020 | 61JDY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2020 | 64LCA56PREDNISONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2020 | 65TCA04SULFUR (SCABICIDE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2020 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2020 | 60ZDP15IVERMECTIN AND COMBINATIONS (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2020 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2020 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2020 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/5/2020 | 62OCA29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/5/2020 | 64BCA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/30/2020 | 64SDY29ZOPICLONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2020 | 61WAK18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2020 | 63HAY25POLYETHYLENE GLYCOL 3350/ELECTROLYTES (CARTHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2020 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2020 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2020 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2020 | 66TCA01ALLOPURINOL (XANTHINE OXIDASE INHIBITOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/28/2020 | 60SCA99ANTACID, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/28/2020 | 60SAA07PRECIPITATED CALCIUM CARBONATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2020 | 62GDL99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2020 | 60YRY99INHIBITOR (GROWTH FACTOR) N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2020 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2020 | 63BCY25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/10/2020 | 64RDA99HORMONE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/10/2020 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/10/2020 | 56BAA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/10/2020 | 66JAA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/9/2020 | 60XCY23TIMOLOL MALEATE (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/7/2020 | 60SDY26SUCRALFATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/7/2020 | 61HDY03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/7/2020 | 62HDY03TROVAFLOXACIN/AZITHROMYCIN (ANTI-MICROBIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2020 | 62ODY28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2020 | 64LCA50PREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2020 | 61GCA47SULFADIAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2020 | 64LCO37HYDROCORTISONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2020 | 61ECA06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2020 | 60SCA28RANITIDINE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2020 | 61MCA99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2020 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/25/2020 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 61GCO81MUPIROCIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 61FCH14CEFADROXIL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/26/2020 | 61BDY02CYPROTERONE ACETATE (ANTI-ANDROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2020 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/25/2020 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/25/2020 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/25/2020 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/25/2020 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/18/2020 | 62OCA44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 2/18/2020 | 61NCH85DULOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/23/2020 | 62GCY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/23/2020 | 60LCA83CELECOXIB (ANALGESIC) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 12/12/2019 | 64SCA29ZOPICLONE | Division of Southeast Imports (DSEI) | |
| 3/11/2019 | 62ODA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is VICENTE ANTONIO ESCOBAR RESTREPO--'s FDA import refusal history?
VICENTE ANTONIO ESCOBAR RESTREPO-- (FEI: 3015149787) has 78 FDA import refusal record(s) in our database, spanning from 3/11/2019 to 9/9/2020.
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. VICENTE ANTONIO ESCOBAR RESTREPO--'s FEI number is 3015149787.
What types of violations has VICENTE ANTONIO ESCOBAR RESTREPO-- received?
VICENTE ANTONIO ESCOBAR RESTREPO-- 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 VICENTE ANTONIO ESCOBAR RESTREPO-- come from?
All FDA import refusal data for VICENTE ANTONIO ESCOBAR RESTREPO-- 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.