TONGCHENG XINGCHUANG PROTECTIVE Products Co Ltd
✅ Low Risk
FEI: 3016777845 • Anqing, Anhui • CHINA
FEI Number
3016777845
Location
Anqing, Anhui
Country
CHINAAddress
No 8 Xinglong Road, Minyingjingjikaifa Tongcheng, Anqing, Anhui, 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
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).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
Frequently Asked Questions
What is TONGCHENG XINGCHUANG PROTECTIVE Products Co Ltd's FDA import refusal history?
TONGCHENG XINGCHUANG PROTECTIVE Products Co Ltd (FEI: 3016777845) has 1 FDA import refusal record(s) in our database, spanning from 7/27/2020 to 7/27/2020.
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. TONGCHENG XINGCHUANG PROTECTIVE Products Co Ltd's FEI number is 3016777845.
What types of violations has TONGCHENG XINGCHUANG PROTECTIVE Products Co Ltd received?
TONGCHENG XINGCHUANG PROTECTIVE Products Co Ltd has been cited for 2 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 TONGCHENG XINGCHUANG PROTECTIVE Products Co Ltd come from?
All FDA import refusal data for TONGCHENG XINGCHUANG PROTECTIVE Products 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.