CSS TECHNOLOGY SOLUTION CO LTD-
⚠️ Moderate Risk
FEI: 3016543579 • Kowloon Bay • HONG KONG
FEI Number
3016543579
Location
Kowloon Bay
Country
HONG KONGAddress
Room 273, 2/F, Phase 2, Yip On Factory; Bldy, Wang Hoi Rd, Kowloon Bay, , Hong Kong
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/7/2021 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 9/29/2020 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 7/20/2020 | 95RHPUV LAMP, GERMICIDAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is CSS TECHNOLOGY SOLUTION CO LTD-'s FDA import refusal history?
CSS TECHNOLOGY SOLUTION CO LTD- (FEI: 3016543579) has 3 FDA import refusal record(s) in our database, spanning from 7/20/2020 to 4/7/2021.
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. CSS TECHNOLOGY SOLUTION CO LTD-'s FEI number is 3016543579.
What types of violations has CSS TECHNOLOGY SOLUTION CO LTD- received?
CSS TECHNOLOGY SOLUTION CO LTD- 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 CSS TECHNOLOGY SOLUTION CO LTD- come from?
All FDA import refusal data for CSS TECHNOLOGY SOLUTION CO 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.