Sin Chew Optics Contact Lens Centre
⚠️ Moderate Risk
FEI: 3010343076 • Singapore • SINGAPORE
FEI Number
3010343076
Location
Singapore
Country
SINGAPOREAddress
301 Upper Thomson Road, , 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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/23/2013 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 9/23/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sin Chew Optics Contact Lens Centre's FDA import refusal history?
Sin Chew Optics Contact Lens Centre (FEI: 3010343076) has 2 FDA import refusal record(s) in our database, spanning from 9/23/2013 to 9/23/2013.
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. Sin Chew Optics Contact Lens Centre's FEI number is 3010343076.
What types of violations has Sin Chew Optics Contact Lens Centre received?
Sin Chew Optics Contact Lens Centre has been cited for 6 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 Sin Chew Optics Contact Lens Centre come from?
All FDA import refusal data for Sin Chew Optics Contact Lens Centre 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.