HERNANDEZ, JOSE ANTONIO
🚨 Critical Risk
FEI: 3017131985 • Bogota, Cundinamarca • COLOMBIA
FEI
FEI Number
3017131985
📍
Location
Bogota, Cundinamarca
🇨🇴
Country
COLOMBIA🏢
Address
Calle 64g 83, 89a, Bogota, Cundinamarca, Colombia
Critical Risk
FDA Import Risk Assessment
77.7
LowModerateHighCritical
This firm has an extensive history of FDA import refusals with severe violations.
Statistics
103
Total Refusals
3
Unique Violations
11/7/2024
Latest Refusal
10/1/2020
Earliest Refusal
Score Breakdown
Violation Severity
75.0×40%
Refusal Volume
74.7×30%
Recency
76.5×20%
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
7568×
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).
11842×
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).
726×
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/7/2024 | 60LCY14CARBAMAZEPINE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/29/2024 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/12/2024 | 56BDH03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/5/2024 | 62UDY13HYDROCODONE BITARTRATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/26/2023 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2023 | 62LCY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2023 | 61ECY06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2023 | 56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2023 | 62GCY41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/23/2023 | 61WCA45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/23/2023 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/23/2023 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/23/2023 | 64XCO07TRETINOIN (KERATOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/23/2023 | 62YCA07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/23/2023 | 66TCA01ALLOPURINOL (XANTHINE OXIDASE INHIBITOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/16/2023 | 62LDY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/14/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/15/2022 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/25/2022 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/25/2022 | 64LCY67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/25/2022 | 64LCY60TRIAMCINOLONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2022 | 64LDY67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2022 | 61WDY52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2022 | 61WDY52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2022 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/27/2022 | 61WQA47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 1/27/2022 | 56CQA73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 1/27/2022 | 66VQA99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 1/10/2022 | 62BCA99ANTI-HYPERLIPIDEMIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/25/2021 | 63NDY04DEXPANTHENOL (CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/25/2021 | 62CDA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2021 | 61MCA06CLONAZEPAM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2021 | 61MCA06CLONAZEPAM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 56HDB24DOXORUBICIN HYDROCHLORIDE (ANTITUMOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 62ODB41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 62ODB40LISINOPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 56KDY03CALCIUM AMPHOMYCIN | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 61MDB41VALPROIC ACID (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 61MDB41VALPROIC ACID (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 61MDB47LACOSAMIDE (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 61MDB42LEVETIRACETAM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/9/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 7/9/2021 | 54YFY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/9/2021 | 61WDY58SERTACONAZOLE NITRATE | Division of Southeast Imports (DSEI) | |
| 7/9/2021 | 61WCY47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 5/5/2021 | 65LCA16HYDROXYPROPYL CELLULOSE (PROTECTANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2021 | 60LCA99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/8/2021 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/3/2021 | 61NCA99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/16/2021 | 60CAA09PHENYLEPHRINE HCL (ADRENERGIC) | Division of Southeast Imports (DSEI) | |
| 2/16/2021 | 60LAA99ANALGESIC, N.E.C. | Division of Southeast Imports (DSEI) | |
| 2/16/2021 | 63BAY29PIRBUTEROL ACETATE (BRONCHODILATOR) | Division of Southeast Imports (DSEI) | |
| 1/11/2021 | 61ECY04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/7/2020 | 62OCA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 12/7/2020 | 60LCA05ASPIRIN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 12/7/2020 | 64GCJ07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2020 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2020 | 61KDA99ANTI-CHOLINERGIC, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/25/2020 | 61KDA99ANTI-CHOLINERGIC, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/9/2020 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 11/9/2020 | 64HCA01BROMHEXINE HCL (EXPECTORANT) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 11/9/2020 | 62LCY47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/30/2020 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/22/2020 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/22/2020 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/22/2020 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/22/2020 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/21/2020 | 64XCY11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/21/2020 | 62KCY11NITAZOXANIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HERNANDEZ, JOSE ANTONIO's FDA import refusal history?
HERNANDEZ, JOSE ANTONIO (FEI: 3017131985) has 103 FDA import refusal record(s) in our database, spanning from 10/1/2020 to 11/7/2024.
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. HERNANDEZ, JOSE ANTONIO's FEI number is 3017131985.
What types of violations has HERNANDEZ, JOSE ANTONIO received?
HERNANDEZ, JOSE ANTONIO 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 HERNANDEZ, JOSE ANTONIO come from?
All FDA import refusal data for HERNANDEZ, JOSE ANTONIO 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.