Placecol Cosmetics (Pty) Ltd
⚠️ Moderate Risk
FEI: 3008405952 • Centurion, Gauteng • SOUTH AFRICA
FEI Number
3008405952
Location
Centurion, Gauteng
Country
SOUTH AFRICAAddress
PO Box 8833, , Centurion, 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
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/11/2011 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 3/11/2011 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 3/11/2011 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
| 3/11/2011 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Placecol Cosmetics (Pty) Ltd's FDA import refusal history?
Placecol Cosmetics (Pty) Ltd (FEI: 3008405952) has 4 FDA import refusal record(s) in our database, spanning from 3/11/2011 to 3/11/2011.
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. Placecol Cosmetics (Pty) Ltd's FEI number is 3008405952.
What types of violations has Placecol Cosmetics (Pty) Ltd received?
Placecol Cosmetics (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 Placecol Cosmetics (Pty) Ltd come from?
All FDA import refusal data for Placecol Cosmetics (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.