Cs Innovation Pte
⚠️ High Risk
FEI: 3006943123 • Sin • SINGAPORE
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/17/2013 | 81MVZSYSTEM, TEST, HOME, HIV-1 | New Orleans District Office (NOL-DO) | |
| 11/28/2012 | 81MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 11/19/2012 | 81MTKKIT, SAMPLE COLLECTION, HIV | Seattle District Office (SEA-DO) | |
| 11/19/2012 | 82MZFTEST, HIV DETECTION | Seattle District Office (SEA-DO) | |
| 11/19/2012 | 82MZFTEST, HIV DETECTION | Seattle District Office (SEA-DO) | |
| 11/6/2012 | 81MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 10/19/2012 | 81MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 10/3/2012 | 81MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 10/3/2012 | 82MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 9/17/2012 | 82MZFTEST, HIV DETECTION | Seattle District Office (SEA-DO) | |
| 9/17/2012 | 82MZFTEST, HIV DETECTION | Seattle District Office (SEA-DO) | |
| 9/12/2012 | 82MZFTEST, HIV DETECTION | Seattle District Office (SEA-DO) | |
| 9/5/2012 | 81MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 8/15/2012 | 82MZFTEST, HIV DETECTION | Seattle District Office (SEA-DO) | |
| 8/8/2012 | 81MTKKIT, SAMPLE COLLECTION, HIV | Seattle District Office (SEA-DO) | |
| 8/6/2012 | 81MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 8/6/2012 | 81MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 8/6/2012 | 81MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 8/6/2012 | 82MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 7/25/2012 | 82MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 7/19/2012 | 81MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 7/17/2012 | 82MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 7/3/2012 | 81MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 6/26/2012 | 82MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 5/7/2012 | 81MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 2/14/2012 | 81MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) | |
| 11/23/2011 | 81MVZSYSTEM, TEST, HOME, HIV-1 | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Cs Innovation Pte's FDA import refusal history?
Cs Innovation Pte (FEI: 3006943123) has 27 FDA import refusal record(s) in our database, spanning from 11/23/2011 to 10/17/2013.
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. Cs Innovation Pte's FEI number is 3006943123.
What types of violations has Cs Innovation Pte received?
Cs Innovation Pte 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 Cs Innovation Pte come from?
All FDA import refusal data for Cs Innovation Pte 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.