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Nam Yang Aloe Co., Ltd.

⚠️ Moderate Risk

FEI: 3003800973 • Seoul • SOUTH KOREA

FEI

FEI Number

3003800973

📍

Location

Seoul

🇰🇷
🏢

Address

8f Taesin B/D 277-35 Sungsu Bong 2ga, , Seoul, , South Korea

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
8/19/2005
Latest Refusal
8/19/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

1181×

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).

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
8/19/2005
66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
8/19/2005
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Nam Yang Aloe Co., Ltd.'s FDA import refusal history?

Nam Yang Aloe Co., Ltd. (FEI: 3003800973) has 2 FDA import refusal record(s) in our database, spanning from 8/19/2005 to 8/19/2005.

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. Nam Yang Aloe Co., Ltd.'s FEI number is 3003800973.

What types of violations has Nam Yang Aloe Co., Ltd. received?

Nam Yang Aloe Co., Ltd. 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 Nam Yang Aloe Co., Ltd. come from?

All FDA import refusal data for Nam Yang Aloe Co., Ltd. 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.