Research Pharmaceutical
⚠️ Moderate Risk
FEI: 3006497359 • Bogota • COLOMBIA
FEI Number
3006497359
Location
Bogota
Country
COLOMBIAAddress
Carrera 106 #15-25, , Bogota, , 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).
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.
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 |
|---|---|---|---|
| 4/1/2014 | 61HCA03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/30/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/30/2013 | 61XAA18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/23/2013 | 62ODS20CAPTOPRIL (ANTI-HYPERTENSIVE - PART II) | Florida District Office (FLA-DO) | |
| 5/13/2013 | 62VCA18ACYCLOVIR (ANTI-VIRAL) | Florida District Office (FLA-DO) | |
| 4/26/2013 | 85MDGSYSTEM, INTRAFALLOPIAN CANNULA | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 7/6/2009 | 62GBA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/2/2009 | 61GAA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2008 | 61HCA03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/22/2008 | 61GAA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/18/2008 | 61EAA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/10/2007 | 61EAA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/10/2007 | 60WAA01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/10/2007 | 61WBA04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/10/2007 | 61XBA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/10/2007 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/10/2007 | 62GBA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/10/2007 | 61GAA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/10/2007 | 61WCA47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Research Pharmaceutical's FDA import refusal history?
Research Pharmaceutical (FEI: 3006497359) has 19 FDA import refusal record(s) in our database, spanning from 10/10/2007 to 4/1/2014.
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. Research Pharmaceutical's FEI number is 3006497359.
What types of violations has Research Pharmaceutical received?
Research Pharmaceutical 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 Research Pharmaceutical come from?
All FDA import refusal data for Research Pharmaceutical 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.