Guangdong Native Produce Import & Export Corporation (Group)
⚠️ Moderate Risk
FEI: 1000111876 • Guangzhou, Guangdong • CHINA
FEI Number
1000111876
Location
Guangzhou, Guangdong
Country
CHINAAddress
108 Jiang Nan Road Central, , Guangzhou, 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
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).
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.
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.
Refusal History
Frequently Asked Questions
What is Guangdong Native Produce Import & Export Corporation (Group)'s FDA import refusal history?
Guangdong Native Produce Import & Export Corporation (Group) (FEI: 1000111876) has 2 FDA import refusal record(s) in our database, spanning from 2/20/2007 to 3/22/2016.
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. Guangdong Native Produce Import & Export Corporation (Group)'s FEI number is 1000111876.
What types of violations has Guangdong Native Produce Import & Export Corporation (Group) received?
Guangdong Native Produce Import & Export Corporation (Group) has been cited for 3 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 Guangdong Native Produce Import & Export Corporation (Group) come from?
All FDA import refusal data for Guangdong Native Produce Import & Export Corporation (Group) 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.