COREPHARM BIO CO LTD
⚠️ Moderate Risk
FEI: 3017898225 • Seongnam, Gyeonggi • SOUTH KOREA
FEI Number
3017898225
Location
Seongnam, Gyeonggi
Country
SOUTH KOREAAddress
Sujeong,Seongnam, 103 Bokjeong-Ro; Sujeong, Seongnam, 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
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/12/2021 | 64LDY19DEXAMETHASONE (GLUCOCORTICOID) | 2280DIRSEXMPT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is COREPHARM BIO CO LTD's FDA import refusal history?
COREPHARM BIO CO LTD (FEI: 3017898225) has 1 FDA import refusal record(s) in our database, spanning from 2/12/2021 to 2/12/2021.
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. COREPHARM BIO CO LTD's FEI number is 3017898225.
What types of violations has COREPHARM BIO CO LTD received?
COREPHARM BIO 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 COREPHARM BIO CO LTD come from?
All FDA import refusal data for COREPHARM BIO 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.