SHANGHAI OGO MEDICAL INSTRUMENT CO., LTD
⚠️ Moderate Risk
FEI: 3017174792 • Shanghai, Shanghai • CHINA
FEI Number
3017174792
Location
Shanghai, Shanghai
Country
CHINAAddress
5f Building 1, No.2 Lane 1515, North Huifeng Road, Fengxian District, , 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
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.
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
Frequently Asked Questions
What is SHANGHAI OGO MEDICAL INSTRUMENT CO., LTD's FDA import refusal history?
SHANGHAI OGO MEDICAL INSTRUMENT CO., LTD (FEI: 3017174792) has 1 FDA import refusal record(s) in our database, spanning from 9/29/2020 to 9/29/2020.
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 OGO MEDICAL INSTRUMENT CO., LTD's FEI number is 3017174792.
What types of violations has SHANGHAI OGO MEDICAL INSTRUMENT CO., LTD received?
SHANGHAI OGO MEDICAL INSTRUMENT CO., LTD 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 SHANGHAI OGO MEDICAL INSTRUMENT CO., LTD come from?
All FDA import refusal data for SHANGHAI OGO MEDICAL INSTRUMENT 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.