SHANGHAI EASTERN PRINTING
⚠️ Moderate Risk
FEI: 3020927418 • Dongguan • CHINA
FEI Number
3020927418
Location
Dongguan
Country
CHINAAddress
Shigu Industrial Zone, , Dongguan, , 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
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.
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 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.
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 |
|---|---|---|---|
| 2/16/2022 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 1/14/2022 | 74DTZOXYGENATOR, CARDIOPULMONARY BYPASS | Division of Southeast Imports (DSEI) | |
| 1/5/2022 | 73CAWGENERATOR, OXYGEN, PORTABLE | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHANGHAI EASTERN PRINTING's FDA import refusal history?
SHANGHAI EASTERN PRINTING (FEI: 3020927418) has 3 FDA import refusal record(s) in our database, spanning from 1/5/2022 to 2/16/2022.
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 EASTERN PRINTING's FEI number is 3020927418.
What types of violations has SHANGHAI EASTERN PRINTING received?
SHANGHAI EASTERN PRINTING 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 EASTERN PRINTING come from?
All FDA import refusal data for SHANGHAI EASTERN PRINTING 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.