ImportRefusal LogoImportRefusal

Dermagen Corporation

✅ Low Risk

FEI: 3004369370 • Manilla • PHILIPPINES

FEI

FEI Number

3004369370

📍

Location

Manilla

🇵🇭
🏢

Address

600 Shaw Boulevard, , Manilla, , Philippines

Low Risk

FDA Import Risk Assessment

23.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
1
Unique Violations
2/9/2005
Latest Refusal
6/7/2004
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

4712×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
2/9/2005
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
6/7/2004
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Dermagen Corporation's FDA import refusal history?

Dermagen Corporation (FEI: 3004369370) has 2 FDA import refusal record(s) in our database, spanning from 6/7/2004 to 2/9/2005.

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. Dermagen Corporation's FEI number is 3004369370.

What types of violations has Dermagen Corporation received?

Dermagen Corporation 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 Dermagen Corporation come from?

All FDA import refusal data for Dermagen Corporation 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.