SHANDONG BLUE SAIL INNOVATION CO LTD
⚠️ Moderate Risk
FEI: 3004150701 • Weifang, Shandong • CHINA
FEI Number
3004150701
Location
Weifang, Shandong
Country
CHINAAddress
Mi He East Rd, Linquxian, Weifang, 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/2/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Los Angeles District Office (LOS-DO) | |
| 5/8/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 5/8/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 5/8/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 5/8/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 5/8/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 5/8/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 4/30/2009 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 508NO 510(K) | Seattle District Office (SEA-DO) |
| 6/28/2005 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is SHANDONG BLUE SAIL INNOVATION CO LTD's FDA import refusal history?
SHANDONG BLUE SAIL INNOVATION CO LTD (FEI: 3004150701) has 9 FDA import refusal record(s) in our database, spanning from 6/28/2005 to 3/2/2011.
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. SHANDONG BLUE SAIL INNOVATION CO LTD's FEI number is 3004150701.
What types of violations has SHANDONG BLUE SAIL INNOVATION CO LTD received?
SHANDONG BLUE SAIL INNOVATION CO LTD has been cited for 5 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 SHANDONG BLUE SAIL INNOVATION CO LTD come from?
All FDA import refusal data for SHANDONG BLUE SAIL INNOVATION 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.