Jinan Bodor Cnc Machine Co Ltd
⚠️ Moderate Risk
FEI: 3008713346 • Jinan, Shandong • CHINA
FEI Number
3008713346
Location
Jinan, Shandong
Country
CHINAAddress
Kanghong Road, Licheng, Jinan, Shandong, 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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
Frequently Asked Questions
What is Jinan Bodor Cnc Machine Co Ltd's FDA import refusal history?
Jinan Bodor Cnc Machine Co Ltd (FEI: 3008713346) has 1 FDA import refusal record(s) in our database, spanning from 9/8/2020 to 9/8/2020.
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. Jinan Bodor Cnc Machine Co Ltd's FEI number is 3008713346.
What types of violations has Jinan Bodor Cnc Machine Co Ltd received?
Jinan Bodor Cnc Machine 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 Jinan Bodor Cnc Machine Co Ltd come from?
All FDA import refusal data for Jinan Bodor Cnc Machine 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.