Harald Nordin
⚠️ Moderate Risk
FEI: 3009275303 • Chailly Sur Montreuxchailly Sur Montreux • SWITZERLAND
FEI Number
3009275303
Location
Chailly Sur Montreuxchailly Sur Montreux
Country
SWITZERLANDAddress
Z.I. La Foge 12, , Chailly Sur Montreuxchailly Sur Montreux, , Switzerland
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
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/11/2016 | 76ELRPOST, ROOT CANAL | Seattle District Office (SEA-DO) | |
| 11/6/2013 | 76EMACEMENT, DENTAL | Philadelphia District Office (PHI-DO) | |
| 9/7/2011 | 76KIFRESIN, ROOT CANAL FILLING | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/7/2011 | 76EKPREAMER, PULP CANAL, ENDODONTIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/7/2011 | 76EFHPAPER, ARTICULATION | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/7/2011 | 76ELRPOST, ROOT CANAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/27/2004 | 76EKPREAMER, PULP CANAL, ENDODONTIC | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Harald Nordin's FDA import refusal history?
Harald Nordin (FEI: 3009275303) has 7 FDA import refusal record(s) in our database, spanning from 8/27/2004 to 7/11/2016.
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. Harald Nordin's FEI number is 3009275303.
What types of violations has Harald Nordin received?
Harald Nordin 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 Harald Nordin come from?
All FDA import refusal data for Harald Nordin 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.