Rhenochem Ag
⚠️ High Risk
FEI: 3001258572 • Basel • SWITZERLAND
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 |
|---|---|---|---|
| 7/14/2008 | 62GDL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/14/2008 | 61KAB05ATROPINE SULFATE (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/14/2008 | 56DCK21GENTAMICIN SULFATE (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/15/2008 | 56ICB76AZITHROMYCIN (MACAROLIDES) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/15/2008 | 61FAE53CEFADROXIL MONOHYDRATE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/15/2008 | 61NDB76PAROXETINE (ANTI-DEPRESSANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/30/2008 | 64LCA41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/30/2008 | 64LCA41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 9/20/2007 | 56CCK70CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/20/2007 | 56CCK60CEFOTAXIME SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/20/2007 | 56AAA10PENICILLIN G, NATURAL | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/20/2007 | 56CCA58CEFOPERAZONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/20/2007 | 56BAA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/11/2007 | 54ADB04VITAMIN B6 (PYRIDOXINE) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/11/2007 | 64LAA20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/11/2007 | 61KAB05ATROPINE SULFATE (ANTI-CHOLINERGIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/11/2007 | 56DCK21GENTAMICIN SULFATE (AMINOGLYCOSIDES) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/11/2007 | 56CCA11CEFAZOLIN SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/7/2007 | 61NDB76PAROXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/7/2007 | 62GAA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Rhenochem Ag's FDA import refusal history?
Rhenochem Ag (FEI: 3001258572) has 20 FDA import refusal record(s) in our database, spanning from 3/7/2007 to 7/14/2008.
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. Rhenochem Ag's FEI number is 3001258572.
What types of violations has Rhenochem Ag received?
Rhenochem Ag 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 Rhenochem Ag come from?
All FDA import refusal data for Rhenochem Ag 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.