ABIO Materials Co., Ltd
⚠️ High Risk
FEI: 3006301466 • Yongin, Gyeonggi • SOUTH KOREA
FEI Number
3006301466
Location
Yongin, Gyeonggi
Country
SOUTH KOREAAddress
Giheung, 719 16-25, Dongbaekjungang-Ro 16beon-Gil, Yongin, Gyeonggi, South Korea
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/15/2025 | 53LH99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 5/29/2025 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/5/2025 | 53LH99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/5/2025 | 53EH99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/5/2016 | 66UBK04HAIR (NATURAL BODY PARTS, INVIVO ONLY) | Seattle District Office (SEA-DO) | |
| 5/4/2010 | 53LH03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is ABIO Materials Co., Ltd's FDA import refusal history?
ABIO Materials Co., Ltd (FEI: 3006301466) has 6 FDA import refusal record(s) in our database, spanning from 5/4/2010 to 7/15/2025.
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. ABIO Materials Co., Ltd's FEI number is 3006301466.
What types of violations has ABIO Materials Co., Ltd received?
ABIO Materials Co., Ltd 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 ABIO Materials Co., Ltd come from?
All FDA import refusal data for ABIO Materials 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.