Paragon Nordic
⚠️ High Risk
FEI: 3005726903 • Vallentuna, Stockholms Lan • SWEDEN
FEI Number
3005726903
Location
Vallentuna, Stockholms Lan
Country
SWEDENAddress
Fabriksvagen 2, , Vallentuna, Stockholms Lan, Sweden
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
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 |
|---|---|---|---|
| 9/1/2010 | 79FRODRESSING, WOUND, DRUG | New York District Office (NYK-DO) | |
| 9/1/2010 | 79FRODRESSING, WOUND, DRUG | New York District Office (NYK-DO) | |
| 3/15/2010 | 64XCQ06SALICYLIC ACID (KERATOLYTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/15/2010 | 64XCQ06SALICYLIC ACID (KERATOLYTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2009 | 62ICQ24HYDROXYUREA (ANTI-NEOPLASTIC) | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 5/28/2009 | 61SDQ99ANTI-ECZEMATIC N.E.C. | 75UNAPPROVED | New England District Office (NWE-DO) |
| 5/28/2009 | 61SDQ99ANTI-ECZEMATIC N.E.C. | 75UNAPPROVED | New England District Office (NWE-DO) |
| 6/25/2008 | 61SDQ99ANTI-ECZEMATIC N.E.C. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 6/18/2008 | 61WDQ28SELENIUM SULFIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 5/29/2008 | 61SDQ99ANTI-ECZEMATIC N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 5/29/2008 | 61SDQ99ANTI-ECZEMATIC N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Paragon Nordic's FDA import refusal history?
Paragon Nordic (FEI: 3005726903) has 11 FDA import refusal record(s) in our database, spanning from 5/29/2008 to 9/1/2010.
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. Paragon Nordic's FEI number is 3005726903.
What types of violations has Paragon Nordic received?
Paragon Nordic has been cited for 4 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 Paragon Nordic come from?
All FDA import refusal data for Paragon Nordic 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.