ZHUHAI GUOJIA NEW MATERIAL CO., LTD
⚠️ Moderate Risk
FEI: 3010165653 • Zhuhai, Guangdong • CHINA
FEI Number
3010165653
Location
Zhuhai, Guangdong
Country
CHINAAddress
No. 697 Sanzao, West Airplane Road; Nanpingzhen, Zhuhai, Guangdong, 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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/30/2015 | 62MDJ08MENTHOL (ANTI-PRURITIC) | Atlanta District Office (ATL-DO) | |
| 10/30/2015 | 62MDJ08MENTHOL (ANTI-PRURITIC) | Atlanta District Office (ATL-DO) | |
| 10/30/2015 | 62MDJ08MENTHOL (ANTI-PRURITIC) | Atlanta District Office (ATL-DO) | |
| 12/5/2014 | 62MBY08MENTHOL (ANTI-PRURITIC) | New Orleans District Office (NOL-DO) | |
| 3/5/2014 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is ZHUHAI GUOJIA NEW MATERIAL CO., LTD's FDA import refusal history?
ZHUHAI GUOJIA NEW MATERIAL CO., LTD (FEI: 3010165653) has 5 FDA import refusal record(s) in our database, spanning from 3/5/2014 to 10/30/2015.
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. ZHUHAI GUOJIA NEW MATERIAL CO., LTD's FEI number is 3010165653.
What types of violations has ZHUHAI GUOJIA NEW MATERIAL CO., LTD received?
ZHUHAI GUOJIA NEW MATERIAL CO., LTD 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 ZHUHAI GUOJIA NEW MATERIAL CO., LTD come from?
All FDA import refusal data for ZHUHAI GUOJIA NEW MATERIAL 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.