Suzhou Tito Industry&Trade Co.Ltd
⚠️ Moderate Risk
FEI: 3008888835 • Suzhousuzhou • CHINA
FEI Number
3008888835
Location
Suzhousuzhou
Country
CHINAAddress
Building D Integrated Boned Zone Ano.200, , Suzhousuzhou, , 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/11/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 2/11/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 2/11/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 4/8/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 2/4/2013 | 53BL01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 473LABELING | New Orleans District Office (NOL-DO) |
| 2/28/2012 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Suzhou Tito Industry&Trade Co.Ltd's FDA import refusal history?
Suzhou Tito Industry&Trade Co.Ltd (FEI: 3008888835) has 6 FDA import refusal record(s) in our database, spanning from 2/28/2012 to 2/11/2015.
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. Suzhou Tito Industry&Trade Co.Ltd's FEI number is 3008888835.
What types of violations has Suzhou Tito Industry&Trade Co.Ltd received?
Suzhou Tito Industry&Trade Co.Ltd 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 Suzhou Tito Industry&Trade Co.Ltd come from?
All FDA import refusal data for Suzhou Tito Industry&Trade 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.