Pjur Group Luxembourg S.A.
⚠️ Moderate Risk
FEI: 3004631594 • Wasserbillig • LUXEMBOURG
FEI Number
3004631594
Location
Wasserbillig
Country
LUXEMBOURGAddress
44 , Esplanade De La Moselle, , Wasserbillig, , Luxembourg
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).
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).
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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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 |
|---|---|---|---|
| 11/29/2013 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 1/23/2012 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Atlanta District Office (ATL-DO) | |
| 6/21/2007 | 80MMSLUBRICANT, VAGINAL, PATIENT | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Pjur Group Luxembourg S.A.'s FDA import refusal history?
Pjur Group Luxembourg S.A. (FEI: 3004631594) has 3 FDA import refusal record(s) in our database, spanning from 6/21/2007 to 11/29/2013.
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. Pjur Group Luxembourg S.A.'s FEI number is 3004631594.
What types of violations has Pjur Group Luxembourg S.A. received?
Pjur Group Luxembourg S.A. 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 Pjur Group Luxembourg S.A. come from?
All FDA import refusal data for Pjur Group Luxembourg S.A. 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.