Union Swiss Pty Ltd.
⚠️ Moderate Risk
FEI: 3005817361 • Boksburg, Western Cape • SOUTH AFRICA
FEI Number
3005817361
Location
Boksburg, Western Cape
Country
SOUTH AFRICAAddress
Plot 71 Middle Road, Bardene EXT 91, Boksburg, Western Cape, South Africa
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
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).
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/28/2018 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 11/28/2018 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 12/17/2012 | 66VAK99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 11/5/2012 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Baltimore District Office (BLT-DO) | |
| 11/5/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 11/5/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 11/3/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 6/23/2011 | 53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 6/23/2011 | 53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Union Swiss Pty Ltd.'s FDA import refusal history?
Union Swiss Pty Ltd. (FEI: 3005817361) has 9 FDA import refusal record(s) in our database, spanning from 6/23/2011 to 11/28/2018.
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. Union Swiss Pty Ltd.'s FEI number is 3005817361.
What types of violations has Union Swiss Pty Ltd. received?
Union Swiss Pty Ltd. 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 Union Swiss Pty Ltd. come from?
All FDA import refusal data for Union Swiss Pty Ltd. 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.