Bio Health World
✅ Low Risk
FEI: 3004784474 • Kyunggi-Do • SOUTH KOREA
FEI Number
3004784474
Location
Kyunggi-Do
Country
SOUTH KOREAAddress
128-2, Onam Eup Namyangju Si, , Kyunggi-Do, , South Korea
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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 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).
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).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/13/2015 | 89JFBTABLE, PHYSICAL THERAPY, MULTI FUNCTION | Southwest Import District Office (SWI-DO) | |
| 12/14/2009 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 6/24/2009 | 89IRTPAD, HEATING, POWERED | Southwest Import District Office (SWI-DO) | |
| 6/24/2009 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Bio Health World's FDA import refusal history?
Bio Health World (FEI: 3004784474) has 4 FDA import refusal record(s) in our database, spanning from 6/24/2009 to 4/13/2015.
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. Bio Health World's FEI number is 3004784474.
What types of violations has Bio Health World received?
Bio Health World has been cited for 5 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 Bio Health World come from?
All FDA import refusal data for Bio Health World 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.