Shenyang Shengda Machinery And Electrical Equipment Co.
⚠️ Moderate Risk
FEI: 3007387861 • Shenyang • CHINA
FEI Number
3007387861
Location
Shenyang
Country
CHINAAddress
42 Zhengxin Roaddadong District, , Shenyang, , 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 |
|---|---|---|---|
| 7/24/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/19/2009 | 82MVZSYSTEM, TEST, HOME, HIV-1 | Cincinnati District Office (CIN-DO) | |
| 4/24/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/13/2009 | 66BAY44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/13/2009 | 66BAY44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Shenyang Shengda Machinery And Electrical Equipment Co.'s FDA import refusal history?
Shenyang Shengda Machinery And Electrical Equipment Co. (FEI: 3007387861) has 5 FDA import refusal record(s) in our database, spanning from 4/13/2009 to 7/24/2009.
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. Shenyang Shengda Machinery And Electrical Equipment Co.'s FEI number is 3007387861.
What types of violations has Shenyang Shengda Machinery And Electrical Equipment Co. received?
Shenyang Shengda Machinery And Electrical Equipment Co. has been cited for 4 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 Shenyang Shengda Machinery And Electrical Equipment Co. come from?
All FDA import refusal data for Shenyang Shengda Machinery And Electrical Equipment Co. 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.