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Energizer Personal Care

⚠️ Moderate Risk

FEI: 3007795627 • Shelton, CT • UNITED STATES

FEI

FEI Number

3007795627

📍

Location

Shelton, CT

🇺🇸
🏢

Address

6 Research Dr, , Shelton, CT, United States

Moderate Risk

FDA Import Risk Assessment

35.5
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
3/1/2024
Latest Refusal
10/24/2011
Earliest Refusal

Score Breakdown

Violation Severity
47.5×40%
Refusal Volume
22.3×30%
Recency
47.6×20%
Frequency
2.4×10%
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

1183×

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).

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

Refusal History

DateProductViolationsDivision
3/1/2024
66PBL05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN)
118NOT LISTED
335LACKS N/C
Division of Northern Border Imports (DNBI)
10/24/2011
66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Florida District Office (FLA-DO)
10/24/2011
66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Energizer Personal Care's FDA import refusal history?

Energizer Personal Care (FEI: 3007795627) has 3 FDA import refusal record(s) in our database, spanning from 10/24/2011 to 3/1/2024.

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. Energizer Personal Care's FEI number is 3007795627.

What types of violations has Energizer Personal Care received?

Energizer Personal Care 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 Energizer Personal Care come from?

All FDA import refusal data for Energizer Personal Care 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.