Medochemie Limited
⚠️ High Risk
FEI: 3002758076 • Limassol • CYPRUS
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/11/2020 | 61NCA55SULPIRIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/23/2017 | 62LCA30MEFLOQUINE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61WCA47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 66SCA27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56CCA73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56CCK73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61WCA47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62VCA19ACYCLOVIR SODIUM (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCA15CLOXACILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56CCA73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56CCA73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56CCK73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56BCA15CLOXACILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56CCA73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 56CCK73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 61WCA47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 56BCA15CLOXACILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 56CCA73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 56BCA15CLOXACILLIN SODIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 56CCP70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2007 | 56ICA10ERYTHROMYCIN (MACROLIDES) | New Orleans District Office (NOL-DO) | |
| 4/24/2007 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | New Orleans District Office (NOL-DO) | |
| 4/24/2007 | 56ICA10ERYTHROMYCIN (MACROLIDES) | New Orleans District Office (NOL-DO) | |
| 12/28/2005 | 61GCA30RIFAMIDE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/11/2005 | 66SDA36VERAPAMIL (VASODILATOR) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 2/11/2005 | 61PDA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Medochemie Limited's FDA import refusal history?
Medochemie Limited (FEI: 3002758076) has 33 FDA import refusal record(s) in our database, spanning from 2/11/2005 to 3/11/2020.
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. Medochemie Limited's FEI number is 3002758076.
What types of violations has Medochemie Limited received?
Medochemie Limited 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 Medochemie Limited come from?
All FDA import refusal data for Medochemie Limited 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.