Kappa City Biotech SAS
⚠️ Moderate Risk
FEI: 3013700017 • Montlucon, Allier • FRANCE
FEI Number
3013700017
Location
Montlucon, Allier
Country
FRANCEAddress
32 Rue Danton, , Montlucon, Allier, France
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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/21/2022 | 91MGXTEST SYSTEM, FOR DRUGS OF ABUSE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 7/21/2022 | 91MGXTEST SYSTEM, FOR DRUGS OF ABUSE | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 6/21/2022 | 75PJDORAL FLUID DRUGS OF ABUSE AND ALCOHOL TEST SPECIMEN COLLECTION DEVICE | Division of Northern Border Imports (DNBI) | |
| 3/18/2022 | 88PPMGENERAL PURPOSE REAGENT | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 2/11/2022 | 91NGLTEST, OPIATES, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 2/11/2022 | 91NGLTEST, OPIATES, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 12/20/2021 | 88PPMGENERAL PURPOSE REAGENT | Division of Southeast Imports (DSEI) | |
| 9/15/2021 | 91MGXTEST SYSTEM, FOR DRUGS OF ABUSE | Division of Southeast Imports (DSEI) | |
| 9/10/2021 | 91MGXTEST SYSTEM, FOR DRUGS OF ABUSE | 237NO PMA | Division of Southeast Imports (DSEI) |
| 8/5/2021 | 91MGXTEST SYSTEM, FOR DRUGS OF ABUSE | Division of Southeast Imports (DSEI) | |
| 11/21/2017 | 91MGXTEST SYSTEM, FOR DRUGS OF ABUSE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Kappa City Biotech SAS's FDA import refusal history?
Kappa City Biotech SAS (FEI: 3013700017) has 11 FDA import refusal record(s) in our database, spanning from 11/21/2017 to 7/21/2022.
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. Kappa City Biotech SAS's FEI number is 3013700017.
What types of violations has Kappa City Biotech SAS received?
Kappa City Biotech SAS has been cited for 5 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 Kappa City Biotech SAS come from?
All FDA import refusal data for Kappa City Biotech SAS 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.