I World Pharmaceutical Co., Ltd.
⚠️ High Risk
FEI: 3014538917 • Namdong, Incheon • SOUTH KOREA
FEI Number
3014538917
Location
Namdong, Incheon
Country
SOUTH KOREAAddress
316 Hambakmoe-Ro, , Namdong, Incheon, 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
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/1/2025 | 60SBY14MAGNESIUM HYDROXIDE (ANTACID) | 3845DRG REF EI | Division of Northeast Imports (DNEI) |
| 3/27/2025 | 60LAY01ACETAMINOPHEN (ANALGESIC) | 3845DRG REF EI | Division of Northeast Imports (DNEI) |
| 2/8/2021 | 60LBR01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is I World Pharmaceutical Co., Ltd.'s FDA import refusal history?
I World Pharmaceutical Co., Ltd. (FEI: 3014538917) has 3 FDA import refusal record(s) in our database, spanning from 2/8/2021 to 4/1/2025.
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. I World Pharmaceutical Co., Ltd.'s FEI number is 3014538917.
What types of violations has I World Pharmaceutical Co., Ltd. received?
I World Pharmaceutical Co., Ltd. has been cited for 2 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 I World Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for I World Pharmaceutical 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.