Pola Cosmetics Pte Ltd
⚠️ Moderate Risk
FEI: 3010322133 • Singapore • SINGAPORE
FEI Number
3010322133
Location
Singapore
Country
SINGAPOREAddress
2 Alexandra Road Delta House, , Singapore, , Singapore
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).
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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 |
|---|---|---|---|
| 2/26/2015 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 2/26/2015 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Cincinnati District Office (CIN-DO) | |
| 12/18/2013 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Pola Cosmetics Pte Ltd's FDA import refusal history?
Pola Cosmetics Pte Ltd (FEI: 3010322133) has 3 FDA import refusal record(s) in our database, spanning from 12/18/2013 to 2/26/2015.
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. Pola Cosmetics Pte Ltd's FEI number is 3010322133.
What types of violations has Pola Cosmetics Pte Ltd received?
Pola Cosmetics Pte 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 Pola Cosmetics Pte Ltd come from?
All FDA import refusal data for Pola Cosmetics Pte 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.