Biosys Co Ltd
⚠️ Moderate Risk
FEI: 3003092075 • Seoul • SOUTH KOREA
FEI Number
3003092075
Location
Seoul
Country
SOUTH KOREAAddress
1005-8 Daechidong Kangnamgu, , Seoul, , 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
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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 |
|---|---|---|---|
| 4/8/2002 | 85HEKMONITOR, HEART SOUND, FETAL, ULTRASONIC | Florida District Office (FLA-DO) | |
| 2/12/2002 | 68XYY99OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL | 336INCONSPICU | Florida District Office (FLA-DO) |
| 2/12/2002 | 68XYY99OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL | 336INCONSPICU | Florida District Office (FLA-DO) |
| 12/26/2001 | 74DPSELECTROCARDIOGRAPH | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Biosys Co Ltd's FDA import refusal history?
Biosys Co Ltd (FEI: 3003092075) has 4 FDA import refusal record(s) in our database, spanning from 12/26/2001 to 4/8/2002.
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. Biosys Co Ltd's FEI number is 3003092075.
What types of violations has Biosys Co Ltd received?
Biosys Co Ltd 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 Biosys Co Ltd come from?
All FDA import refusal data for Biosys 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.