APROGEN PHARMACEUTICALS, INC.
⚠️ Moderate Risk
FEI: 3017103615 • Hwaseong, Gyeonggi • SOUTH KOREA
FEI Number
3017103615
Location
Hwaseong, Gyeonggi
Country
SOUTH KOREAAddress
16 Dumeori-gil, , Hwaseong, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/12/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 1/12/2021 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 1/12/2021 | 54AFP13VITAMIN C (ASCORBIC ACID) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is APROGEN PHARMACEUTICALS, INC.'s FDA import refusal history?
APROGEN PHARMACEUTICALS, INC. (FEI: 3017103615) has 3 FDA import refusal record(s) in our database, spanning from 1/12/2021 to 1/12/2021.
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. APROGEN PHARMACEUTICALS, INC.'s FEI number is 3017103615.
What types of violations has APROGEN PHARMACEUTICALS, INC. received?
APROGEN PHARMACEUTICALS, INC. 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 APROGEN PHARMACEUTICALS, INC. come from?
All FDA import refusal data for APROGEN PHARMACEUTICALS, INC. 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.