Qingdao Shuang
⚠️ Moderate Risk
FEI: 3003096921 • Qingdao • CHINA
FEI Number
3003096921
Location
Qingdao
Country
CHINAAddress
Dong Dianzi, South Of Jiaozhou, , Qingdao, , 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/13/2013 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | New York District Office (NYK-DO) | |
| 8/13/2013 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | New York District Office (NYK-DO) | |
| 8/13/2013 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | New York District Office (NYK-DO) | |
| 8/13/2013 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | New York District Office (NYK-DO) | |
| 8/13/2013 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | New York District Office (NYK-DO) | |
| 8/13/2013 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Qingdao Shuang's FDA import refusal history?
Qingdao Shuang (FEI: 3003096921) has 6 FDA import refusal record(s) in our database, spanning from 8/13/2013 to 8/13/2013.
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. Qingdao Shuang's FEI number is 3003096921.
What types of violations has Qingdao Shuang received?
Qingdao Shuang 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 Qingdao Shuang come from?
All FDA import refusal data for Qingdao Shuang 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.