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Park Jin Yong

⚠️ High Risk

FEI: 3008567310 • Gyeongsangbuk • SOUTH KOREA

FEI

FEI Number

3008567310

📍

Location

Gyeongsangbuk

🇰🇷
🏢

Address

Ji Apt 201 Namyul Ri Seokjeop, , Gyeongsangbuk, , South Korea

High Risk

FDA Import Risk Assessment

56.4
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

12
Total Refusals
2
Unique Violations
11/1/2010
Latest Refusal
11/1/2010
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
41.3×30%
Recency
0.0×20%
Frequency
100.0×10%
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

759×

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).

163×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
11/1/2010
62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2010
60LBA05ASPIRIN (ANALGESIC)
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2010
66SDA46CILOSTAZOL (VASODILATOR)
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2010
61TDA06DIMENHYDRINATE (ANTI-EMETIC/NAUSEANT)
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2010
61NDA69GABAPENTIN (ANTI-DEPRESSANT)
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2010
61NDA03AMITRIPTYLINE HCL (ANTI-DEPRESSANT)
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2010
61PDA99ANTI-DIABETIC N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2010
61PDA09GLIPIZIDE (ANTI-DIABETIC)
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2010
60LDA14CARBAMAZEPINE (ANALGESIC)
75UNAPPROVED
New York District Office (NYK-DO)
11/1/2010
54AEA90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
16DIRECTIONS
New York District Office (NYK-DO)
11/1/2010
55PP44SULFUR DIOXIDE (PHARMACEUTIC NECESSITY - ANTIOXIDANT)
16DIRECTIONS
New York District Office (NYK-DO)
11/1/2010
54AEA04VITAMIN B6 (PYRIDOXINE)
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Park Jin Yong's FDA import refusal history?

Park Jin Yong (FEI: 3008567310) has 12 FDA import refusal record(s) in our database, spanning from 11/1/2010 to 11/1/2010.

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 Jin Yong's FEI number is 3008567310.

What types of violations has Park Jin Yong received?

Park Jin Yong 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 Park Jin Yong come from?

All FDA import refusal data for Park Jin Yong 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.