Pharmaswiss Doo
⚠️ Moderate Risk
FEI: 3010476738 • Ljubljana, Osrednjeslovenska • SLOVENIA
FEI Number
3010476738
Location
Ljubljana, Osrednjeslovenska
Country
SLOVENIAAddress
Dolenjska Cesta 242c, , Ljubljana, Osrednjeslovenska, Slovenia
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 473LABELING | Los Angeles District Office (LOS-DO) |
| 1/7/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 473LABELING | Los Angeles District Office (LOS-DO) |
| 1/7/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 473LABELING | Los Angeles District Office (LOS-DO) |
| 1/7/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 473LABELING | Los Angeles District Office (LOS-DO) |
| 1/7/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 473LABELING | Los Angeles District Office (LOS-DO) |
| 1/7/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 473LABELING | Los Angeles District Office (LOS-DO) |
| 1/7/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 473LABELING | Los Angeles District Office (LOS-DO) |
| 1/7/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/7/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/7/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/7/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/7/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Pharmaswiss Doo's FDA import refusal history?
Pharmaswiss Doo (FEI: 3010476738) has 12 FDA import refusal record(s) in our database, spanning from 1/7/2014 to 1/7/2014.
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. Pharmaswiss Doo's FEI number is 3010476738.
What types of violations has Pharmaswiss Doo received?
Pharmaswiss Doo 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 Pharmaswiss Doo come from?
All FDA import refusal data for Pharmaswiss Doo 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.