Concorde Marketing Pte Ltd
⚠️ Moderate Risk
FEI: 3008978601 • Singapore • SINGAPORE
FEI Number
3008978601
Location
Singapore
Country
SINGAPOREAddress
No 1 Coleman Street, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/20/2012 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/20/2012 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/20/2012 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/20/2012 | 53AY02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Concorde Marketing Pte Ltd's FDA import refusal history?
Concorde Marketing Pte Ltd (FEI: 3008978601) has 4 FDA import refusal record(s) in our database, spanning from 1/20/2012 to 9/20/2012.
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. Concorde Marketing Pte Ltd's FEI number is 3008978601.
What types of violations has Concorde Marketing Pte Ltd received?
Concorde Marketing Pte Ltd has been cited for 1 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 Concorde Marketing Pte Ltd come from?
All FDA import refusal data for Concorde Marketing 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.