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Dermal Photonic Corp

✅ Low Risk

FEI: 3015109022 • Danvers, MA • UNITED STATES

FEI

FEI Number

3015109022

📍

Location

Danvers, MA

🇺🇸
🏢

Address

153 Andover St Ste 111, , Danvers, MA, United States

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/28/2019
Latest Refusal
10/28/2019
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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).

Refusal History

DateProductViolationsDivision
10/28/2019
79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION
118NOT LISTED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Dermal Photonic Corp's FDA import refusal history?

Dermal Photonic Corp (FEI: 3015109022) has 1 FDA import refusal record(s) in our database, spanning from 10/28/2019 to 10/28/2019.

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. Dermal Photonic Corp's FEI number is 3015109022.

What types of violations has Dermal Photonic Corp received?

Dermal Photonic Corp 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 Dermal Photonic Corp come from?

All FDA import refusal data for Dermal Photonic Corp 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.