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Camellia Co., Ltd.

⚠️ Moderate Risk

FEI: 3004819799 • Sungnam-shi, Gyeonggido • SOUTH KOREA

FEI

FEI Number

3004819799

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Location

Sungnam-shi, Gyeonggido

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🏢

Address

Rm 1312 Sk North Techno Park 190-1, Sangdaewon-Dong, Jungwon-Gu, Sungnam-shi, Gyeonggido, South Korea

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
1/11/2011
Latest Refusal
2/2/2009
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
10.3×10%
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

1182×

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).

Refusal History

DateProductViolationsDivision
1/11/2011
61HBY99ANTI-BACTERIAL, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
2/2/2009
60LBY99ANALGESIC, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Camellia Co., Ltd.'s FDA import refusal history?

Camellia Co., Ltd. (FEI: 3004819799) has 2 FDA import refusal record(s) in our database, spanning from 2/2/2009 to 1/11/2011.

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. Camellia Co., Ltd.'s FEI number is 3004819799.

What types of violations has Camellia Co., Ltd. received?

Camellia Co., Ltd. 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 Camellia Co., Ltd. come from?

All FDA import refusal data for Camellia 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.