Absology Co., Ltd.
⚠️ Moderate Risk
FEI: 3017064580 • Anyang, Gyeonggi • SOUTH KOREA
FEI Number
3017064580
Location
Anyang, Gyeonggi
Country
SOUTH KOREAAddress
Simin-Daero 383, Dongan, # 1303 Digital Empire "B", 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/23/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Absology Co., Ltd.'s FDA import refusal history?
Absology Co., Ltd. (FEI: 3017064580) has 1 FDA import refusal record(s) in our database, spanning from 9/23/2020 to 9/23/2020.
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. Absology Co., Ltd.'s FEI number is 3017064580.
What types of violations has Absology Co., Ltd. received?
Absology Co., Ltd. has been cited for 1 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 Absology Co., Ltd. come from?
All FDA import refusal data for Absology 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.