Genfar S.A. Parque Industrial Caucadesa
⚠️ Moderate Risk
FEI: 3003947711 • Villa Rica, Valle Del Cauca • COLOMBIA
FEI Number
3003947711
Location
Villa Rica, Valle Del Cauca
Country
COLOMBIAAddress
Km. 43 via Panamericana Cali-Santander, Jamundi-Santander De Quilichao, Villa Rica, Valle Del Cauca, Colombia
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/29/2020 | 56ICY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/15/2019 | 64BCY25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2016 | 64BCA25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/20/2016 | 61PCA55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/20/2016 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/16/2016 | 56YYA99ANTIBIOTIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/6/2014 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/14/2014 | 61TCA31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/25/2014 | 64LCO03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/16/2014 | 56BCA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/9/2014 | 64BCA24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/12/2014 | 68YYY10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 3/12/2014 | 68YYY10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 3/12/2014 | 68YYY10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 10/6/2011 | 62GCY90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/3/2008 | 62LCB50METRONIDAZOLE HYDROCHLORIDE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/27/2007 | 62LCB40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/22/2005 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Genfar S.A. Parque Industrial Caucadesa's FDA import refusal history?
Genfar S.A. Parque Industrial Caucadesa (FEI: 3003947711) has 18 FDA import refusal record(s) in our database, spanning from 7/22/2005 to 7/29/2020.
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. Genfar S.A. Parque Industrial Caucadesa's FEI number is 3003947711.
What types of violations has Genfar S.A. Parque Industrial Caucadesa received?
Genfar S.A. Parque Industrial Caucadesa 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 Genfar S.A. Parque Industrial Caucadesa come from?
All FDA import refusal data for Genfar S.A. Parque Industrial Caucadesa 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.