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Park Pill Jun

⚠️ Moderate Risk

FEI: 3004011807 • Kyungki-Do • SOUTH KOREA

FEI

FEI Number

3004011807

📍

Location

Kyungki-Do

🇰🇷
🏢

Address

5713 Wonmi-Ku, , Kyungki-Do, , South Korea

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/13/2003
Latest Refusal
6/13/2003
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

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
6/13/2003
64XBH11ISOTRETINOIN (KERATOLYTIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Park Pill Jun's FDA import refusal history?

Park Pill Jun (FEI: 3004011807) has 1 FDA import refusal record(s) in our database, spanning from 6/13/2003 to 6/13/2003.

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. Park Pill Jun's FEI number is 3004011807.

What types of violations has Park Pill Jun received?

Park Pill Jun has been cited for 1 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 Park Pill Jun come from?

All FDA import refusal data for Park Pill Jun 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.