Annique Health And Beauty (Pty) Ltd
⚠️ Moderate Risk
FEI: 3011219625 • Johannesburg, Gauteng • SOUTH AFRICA
FEI Number
3011219625
Location
Johannesburg, Gauteng
Country
SOUTH AFRICAAddress
Route 21 Corporate Park Regency Drive No, , Johannesburg, Gauteng, 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
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).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/14/2015 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | Atlanta District Office (ATL-DO) |
| 9/14/2015 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 9/14/2015 | 53LB10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Annique Health And Beauty (Pty) Ltd's FDA import refusal history?
Annique Health And Beauty (Pty) Ltd (FEI: 3011219625) has 3 FDA import refusal record(s) in our database, spanning from 9/14/2015 to 9/14/2015.
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. Annique Health And Beauty (Pty) Ltd's FEI number is 3011219625.
What types of violations has Annique Health And Beauty (Pty) Ltd received?
Annique Health And Beauty (Pty) Ltd has been cited for 2 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 Annique Health And Beauty (Pty) Ltd come from?
All FDA import refusal data for Annique Health And Beauty (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.