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DTS MG

⚠️ Moderate Risk

FEI: 3008395822 • Seoul, Seoul Teugbyeolsi • SOUTH KOREA

FEI

FEI Number

3008395822

📍

Location

Seoul, Seoul Teugbyeolsi

🇰🇷
🏢

Address

275-29 #402, Daegun Indus Town, Ga, SEONGDONG-GU, Seoul, Seoul Teugbyeolsi, South Korea

Moderate Risk

FDA Import Risk Assessment

49.0
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
2
Unique Violations
3/21/2025
Latest Refusal
3/17/2025
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
68.5×20%
Frequency
20.0×10%
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

32801×

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.

751×

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

DateProductViolationsDivision
3/21/2025
66VCL99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of West Coast Imports (DWCI)
3/17/2025
80QNSLOW DEAD SPACE NEEDLE, SINGLE LUMEN, HYPODERMIC
3280FRNMFGREG
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is DTS MG's FDA import refusal history?

DTS MG (FEI: 3008395822) has 2 FDA import refusal record(s) in our database, spanning from 3/17/2025 to 3/21/2025.

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. DTS MG's FEI number is 3008395822.

What types of violations has DTS MG received?

DTS MG 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 DTS MG come from?

All FDA import refusal data for DTS MG 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.