Creative Concepts Manufacturing Ltd.
⚠️ Moderate Risk
FEI: 3008240989 • Kowloon • CHINA
FEI Number
3008240989
Location
Kowloon
Country
CHINAAddress
1210-c 12/f Harbour Center Tower 1, 1 Hok Cheung Street Hung Hom, Kowloon, , China
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
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.
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/13/2015 | 76NOBUNIT,ULTRAVIOLET SANITATION/STERILIZATION(FOR TOOTHBRUSHES),NON-STERILE | New England District Office (NWE-DO) | |
| 2/13/2015 | 76NOBUNIT,ULTRAVIOLET SANITATION/STERILIZATION(FOR TOOTHBRUSHES),NON-STERILE | New England District Office (NWE-DO) | |
| 9/19/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Creative Concepts Manufacturing Ltd.'s FDA import refusal history?
Creative Concepts Manufacturing Ltd. (FEI: 3008240989) has 3 FDA import refusal record(s) in our database, spanning from 9/19/2012 to 2/13/2015.
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. Creative Concepts Manufacturing Ltd.'s FEI number is 3008240989.
What types of violations has Creative Concepts Manufacturing Ltd. received?
Creative Concepts Manufacturing Ltd. has been cited for 5 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 Creative Concepts Manufacturing Ltd. come from?
All FDA import refusal data for Creative Concepts Manufacturing 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.