Guotai Intl Group Hua Tai Ie Co Tl
⚠️ Moderate Risk
FEI: 3007781188 • Zhangjiagangzhangjiagang • CHINA
FEI Number
3007781188
Location
Zhangjiagangzhangjiagang
Country
CHINAAddress
D Fl 3 No 1 Bldg No 4, , Zhangjiagangzhangjiagang, , 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).
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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).
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/24/2009 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 11/24/2009 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 11/4/2009 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/4/2009 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/4/2009 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/4/2009 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Guotai Intl Group Hua Tai Ie Co Tl's FDA import refusal history?
Guotai Intl Group Hua Tai Ie Co Tl (FEI: 3007781188) has 6 FDA import refusal record(s) in our database, spanning from 11/4/2009 to 11/24/2009.
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. Guotai Intl Group Hua Tai Ie Co Tl's FEI number is 3007781188.
What types of violations has Guotai Intl Group Hua Tai Ie Co Tl received?
Guotai Intl Group Hua Tai Ie Co Tl has been cited for 7 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 Guotai Intl Group Hua Tai Ie Co Tl come from?
All FDA import refusal data for Guotai Intl Group Hua Tai Ie Co Tl 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.