ImportRefusal LogoImportRefusal

Derma Care Research Labs LLC

⚠️ Moderate Risk

FEI: 3013570706 • Daytona Beach, FL • UNITED STATES

FEI

FEI Number

3013570706

📍

Location

Daytona Beach, FL

🇺🇸
🏢

Address

440 Fentress Blvd, , Daytona Beach, FL, United States

Moderate Risk

FDA Import Risk Assessment

42.4
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
7/18/2025
Latest Refusal
7/18/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
75.5×20%
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

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
7/18/2025
66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Northeast Imports (DNEI)
7/18/2025
66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Derma Care Research Labs LLC's FDA import refusal history?

Derma Care Research Labs LLC (FEI: 3013570706) has 2 FDA import refusal record(s) in our database, spanning from 7/18/2025 to 7/18/2025.

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. Derma Care Research Labs LLC's FEI number is 3013570706.

What types of violations has Derma Care Research Labs LLC received?

Derma Care Research Labs LLC 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 Derma Care Research Labs LLC come from?

All FDA import refusal data for Derma Care Research Labs LLC 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.