TIANBO FIRST AID PRODUCT CO LTD
✅ Low Risk
FEI: 3012930522 • Ningbo • CHINA
FEI Number
3012930522
Location
Ningbo
Country
CHINAAddress
Yushantou Village Dongq, , Ningbo, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2016 | 80OKIEMERGENCY RESPONSE SAFETY KIT | 341REGISTERED | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is TIANBO FIRST AID PRODUCT CO LTD's FDA import refusal history?
TIANBO FIRST AID PRODUCT CO LTD (FEI: 3012930522) has 1 FDA import refusal record(s) in our database, spanning from 12/20/2016 to 12/20/2016.
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. TIANBO FIRST AID PRODUCT CO LTD's FEI number is 3012930522.
What types of violations has TIANBO FIRST AID PRODUCT CO LTD received?
TIANBO FIRST AID PRODUCT CO LTD has been cited for 1 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 TIANBO FIRST AID PRODUCT CO LTD come from?
All FDA import refusal data for TIANBO FIRST AID PRODUCT 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.