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Pyungang Oriental Medicine Clinic

⚠️ Moderate Risk

FEI: 3005787651 • Ansanansan • SOUTH KOREA

FEI

FEI Number

3005787651

📍

Location

Ansanansan

🇰🇷
🏢

Address

Millennium Plaza 3th729, Gojan Dong, , Ansanansan, , South Korea

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/31/2006
Latest Refusal
7/31/2006
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
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

32602×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

752×

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
7/31/2006
54YBA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3260NO ENGLISH
75UNAPPROVED
Los Angeles District Office (LOS-DO)
7/31/2006
54YBA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3260NO ENGLISH
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Pyungang Oriental Medicine Clinic's FDA import refusal history?

Pyungang Oriental Medicine Clinic (FEI: 3005787651) has 2 FDA import refusal record(s) in our database, spanning from 7/31/2006 to 7/31/2006.

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. Pyungang Oriental Medicine Clinic's FEI number is 3005787651.

What types of violations has Pyungang Oriental Medicine Clinic received?

Pyungang Oriental Medicine Clinic 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 Pyungang Oriental Medicine Clinic come from?

All FDA import refusal data for Pyungang Oriental Medicine Clinic 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.