GOLDCREDIT INTERNATIONAL TRADING CO., LTD.
⚠️ Moderate Risk
FEI: 3006639573 • Wuxi, Jiangsu • CHINA
FEI Number
3006639573
Location
Wuxi, Jiangsu
Country
CHINAAddress
8-801 Haoyuan Bldg., Taihu Square, , Wuxi, Jiangsu, 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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 3/25/2013 | 64AAL99DISINFECTANT N.E.C. | New York District Office (NYK-DO) | |
| 3/25/2013 | 64AAL99DISINFECTANT N.E.C. | New York District Office (NYK-DO) | |
| 10/27/2010 | 64AAL99DISINFECTANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/15/2010 | 64AAL99DISINFECTANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is GOLDCREDIT INTERNATIONAL TRADING CO., LTD.'s FDA import refusal history?
GOLDCREDIT INTERNATIONAL TRADING CO., LTD. (FEI: 3006639573) has 4 FDA import refusal record(s) in our database, spanning from 9/15/2010 to 3/25/2013.
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. GOLDCREDIT INTERNATIONAL TRADING CO., LTD.'s FEI number is 3006639573.
What types of violations has GOLDCREDIT INTERNATIONAL TRADING CO., LTD. received?
GOLDCREDIT INTERNATIONAL TRADING CO., 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 GOLDCREDIT INTERNATIONAL TRADING CO., LTD. come from?
All FDA import refusal data for GOLDCREDIT INTERNATIONAL TRADING 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.