Zhongshan Hongtian Plastics Enterprise Co. Ltd
✅ Low Risk
FEI: 3009094319 • Zhongshan, GuangDong • CHINA
FEI Number
3009094319
Location
Zhongshan, GuangDong
Country
CHINAAddress
Pingnan Industry, District Sanxiang, Zhongshan, GuangDong, China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
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.
Refusal History
Frequently Asked Questions
What is Zhongshan Hongtian Plastics Enterprise Co. Ltd's FDA import refusal history?
Zhongshan Hongtian Plastics Enterprise Co. Ltd (FEI: 3009094319) has 1 FDA import refusal record(s) in our database, spanning from 10/18/2011 to 10/18/2011.
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. Zhongshan Hongtian Plastics Enterprise Co. Ltd's FEI number is 3009094319.
What types of violations has Zhongshan Hongtian Plastics Enterprise Co. Ltd received?
Zhongshan Hongtian Plastics Enterprise Co. Ltd 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 Zhongshan Hongtian Plastics Enterprise Co. Ltd come from?
All FDA import refusal data for Zhongshan Hongtian Plastics Enterprise 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.