Dong IL Pharm Co., Ltd.
⚠️ Moderate Risk
FEI: 3015116573 • Eumseong, Chungcheongbuk • SOUTH KOREA
FEI Number
3015116573
Location
Eumseong, Chungcheongbuk
Country
SOUTH KOREAAddress
26 Rinosandan-Gil, Maengdong-Myeon, Eumseong, Chungcheongbuk, 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
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).
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.
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.
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 |
|---|---|---|---|
| 5/28/2021 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 5/28/2021 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 5/27/2021 | 62FCG17HYDROGEN PEROXIDE (SOL) (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/20/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of West Coast Imports (DWCI) | |
| 4/24/2019 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Dong IL Pharm Co., Ltd.'s FDA import refusal history?
Dong IL Pharm Co., Ltd. (FEI: 3015116573) has 5 FDA import refusal record(s) in our database, spanning from 4/24/2019 to 5/28/2021.
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. Dong IL Pharm Co., Ltd.'s FEI number is 3015116573.
What types of violations has Dong IL Pharm Co., Ltd. received?
Dong IL Pharm Co., Ltd. has been cited for 4 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 Dong IL Pharm Co., Ltd. come from?
All FDA import refusal data for Dong IL Pharm 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.