Medytox Inc.
⚠️ High Risk
FEI: 3015534270 • Gangnam, Seoul Teugbyeolsi • SOUTH KOREA
FEI Number
3015534270
Location
Gangnam, Seoul Teugbyeolsi
Country
SOUTH KOREAAddress
8f 626, Teheran-Ro, , Gangnam, Seoul Teugbyeolsi, 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
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).
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.
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 |
|---|---|---|---|
| 12/16/2025 | 58PIP05ONABOTULINUMTOXINA | Division of Southeast Imports (DSEI) | |
| 11/18/2025 | 58PDY05ONABOTULINUMTOXINA | Division of West Coast Imports (DWCI) | |
| 11/14/2025 | 58PCY05ONABOTULINUMTOXINA | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Medytox Inc.'s FDA import refusal history?
Medytox Inc. (FEI: 3015534270) has 3 FDA import refusal record(s) in our database, spanning from 11/14/2025 to 12/16/2025.
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. Medytox Inc.'s FEI number is 3015534270.
What types of violations has Medytox Inc. received?
Medytox Inc. has been cited for 3 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 Medytox Inc. come from?
All FDA import refusal data for Medytox 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.