Shanghai Dasheng Health Products manufacture Co. L
⚠️ Moderate Risk
FEI: 3006534188 • Shanghai, Shanghai • CHINA
FEI Number
3006534188
Location
Shanghai, Shanghai
Country
CHINAAddress
No. 228 Shihui Road, Songjiang, Shanghai, Shanghai, 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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/5/2021 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Northern Border Imports (DNBI) |
| 2/1/2021 | 80FXXMASK, SURGICAL | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 1/20/2021 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 1/5/2021 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 9/18/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 7/27/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 7/6/2020 | 80FXXMASK, SURGICAL | Division of Southeast Imports (DSEI) | |
| 6/26/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 479DV QUALITY | Division of Northeast Imports (DNEI) |
| 6/24/2020 | 80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southeast Imports (DSEI) |
| 6/5/2020 | 80NZJRESPIRATOR, N95, HOME USE | 479DV QUALITY | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Shanghai Dasheng Health Products manufacture Co. L's FDA import refusal history?
Shanghai Dasheng Health Products manufacture Co. L (FEI: 3006534188) has 11 FDA import refusal record(s) in our database, spanning from 6/5/2020 to 2/5/2021.
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. Shanghai Dasheng Health Products manufacture Co. L's FEI number is 3006534188.
What types of violations has Shanghai Dasheng Health Products manufacture Co. L received?
Shanghai Dasheng Health Products manufacture Co. L 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 Shanghai Dasheng Health Products manufacture Co. L come from?
All FDA import refusal data for Shanghai Dasheng Health Products manufacture Co. L 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.