Sterling Mercantile Pte Ltd
⚠️ Moderate Risk
FEI: 3007202124 • Singapore • SINGAPORE
FEI Number
3007202124
Location
Singapore
Country
SINGAPOREAddress
120 Lower Delta Road, #12-10 Cendex Centre, 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).
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/23/2013 | 76EFWTOOTHBRUSH, MANUAL | Division of Northeast Imports (DNEI) | |
| 7/23/2013 | 76EFWTOOTHBRUSH, MANUAL | Division of Northeast Imports (DNEI) | |
| 6/13/2011 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/3/2009 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | New York District Office (NYK-DO) | |
| 9/3/2009 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | New York District Office (NYK-DO) | |
| 9/3/2009 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sterling Mercantile Pte Ltd's FDA import refusal history?
Sterling Mercantile Pte Ltd (FEI: 3007202124) has 6 FDA import refusal record(s) in our database, spanning from 9/3/2009 to 7/23/2013.
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. Sterling Mercantile Pte Ltd's FEI number is 3007202124.
What types of violations has Sterling Mercantile Pte Ltd received?
Sterling Mercantile Pte Ltd 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 Sterling Mercantile Pte Ltd come from?
All FDA import refusal data for Sterling Mercantile 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.