OSANG Healthcare CO., LTD.
⚠️ Moderate Risk
FEI: 3004146366 • Anyang, Gyeonggi • SOUTH KOREA
FEI Number
3004146366
Location
Anyang, Gyeonggi
Country
SOUTH KOREAAddress
132 Anyangcheondong-Ro; Dongan, , Anyang, Gyeonggi, South Korea
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
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.
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
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 |
|---|---|---|---|
| 1/29/2021 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/8/2021 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/15/2007 | 75CGAGLUCOSE OXIDASE, GLUCOSE | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is OSANG Healthcare CO., LTD.'s FDA import refusal history?
OSANG Healthcare CO., LTD. (FEI: 3004146366) has 3 FDA import refusal record(s) in our database, spanning from 3/15/2007 to 1/29/2021.
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. OSANG Healthcare CO., LTD.'s FEI number is 3004146366.
What types of violations has OSANG Healthcare CO., LTD. received?
OSANG Healthcare CO., LTD. has been cited for 3 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 OSANG Healthcare CO., LTD. come from?
All FDA import refusal data for OSANG Healthcare 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.