Budline Co Ltd
⚠️ Moderate Risk
FEI: 3006896938 • Shenzhen, Guangdong • CHINA
FEI Number
3006896938
Location
Shenzhen, Guangdong
Country
CHINAAddress
9 Hongweilu, Longgang, Shenzhen, 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
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/5/2008 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 126FAILS STD | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Budline Co Ltd's FDA import refusal history?
Budline Co Ltd (FEI: 3006896938) has 1 FDA import refusal record(s) in our database, spanning from 7/5/2008 to 7/5/2008.
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. Budline Co Ltd's FEI number is 3006896938.
What types of violations has Budline Co Ltd received?
Budline 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 Budline Co Ltd come from?
All FDA import refusal data for Budline 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.