Chuan Lee Hin Tyres Trading
⚠️ Moderate Risk
FEI: 3006219927 • Singapore • SINGAPORE
FEI Number
3006219927
Location
Singapore
Country
SINGAPOREAddress
No 50 Bukit Batok 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).
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 |
|---|---|---|---|
| 2/19/2008 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | New York District Office (NYK-DO) | |
| 2/15/2008 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | New York District Office (NYK-DO) | |
| 1/2/2008 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | New York District Office (NYK-DO) | |
| 1/2/2008 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | New York District Office (NYK-DO) | |
| 1/2/2008 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | New York District Office (NYK-DO) | |
| 1/2/2008 | 63RAY99DENTAL CARIES PROPHYLACTIC N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Chuan Lee Hin Tyres Trading's FDA import refusal history?
Chuan Lee Hin Tyres Trading (FEI: 3006219927) has 6 FDA import refusal record(s) in our database, spanning from 1/2/2008 to 2/19/2008.
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. Chuan Lee Hin Tyres Trading's FEI number is 3006219927.
What types of violations has Chuan Lee Hin Tyres Trading received?
Chuan Lee Hin Tyres Trading 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 Chuan Lee Hin Tyres Trading come from?
All FDA import refusal data for Chuan Lee Hin Tyres Trading 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.