Impex Quimica Sa
⚠️ High Risk
FEI: 3001554786 • Barcelona, Barcelona • SPAIN
FEI Number
3001554786
Location
Barcelona, Barcelona
Country
SPAINAddress
Calle Funoses-Llussa 28, , Barcelona, Barcelona, Spain
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/25/2005 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/25/2005 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/10/2005 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/4/2005 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/29/2005 | 56BCS03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/31/2005 | 56YCB99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/31/2005 | 56YCB99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/28/2005 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/10/2005 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 2/10/2005 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/9/2004 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 179AGR RX | Florida District Office (FLA-DO) |
| 12/9/2004 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/9/2004 | 56BCS07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/10/2004 | 56YAB99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/10/2004 | 56YCB99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/10/2004 | 56YCB99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/6/2002 | 56DYS11DIHYDROSTREPTOMYCIN SULFATE (AMINOGLYCOSIDES) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Impex Quimica Sa's FDA import refusal history?
Impex Quimica Sa (FEI: 3001554786) has 17 FDA import refusal record(s) in our database, spanning from 11/6/2002 to 7/25/2005.
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. Impex Quimica Sa's FEI number is 3001554786.
What types of violations has Impex Quimica Sa received?
Impex Quimica Sa 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 Impex Quimica Sa come from?
All FDA import refusal data for Impex Quimica Sa 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.