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Coola Suncare

⚠️ High Risk

FEI: 3008144135 • Bonsall, CA • UNITED STATES

FEI

FEI Number

3008144135

📍

Location

Bonsall, CA

🇺🇸
🏢

Address

31305 Via Mariposa Ct, , Bonsall, CA, United States

High Risk

FDA Import Risk Assessment

54.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

8
Total Refusals
1
Unique Violations
6/15/2010
Latest Refusal
6/15/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
80.0×10%
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

758×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
6/15/2010
66PBO99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2010
66PBO99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2010
66PBO99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2010
66PBO99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2010
66PBO99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2010
66PBO99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2010
66PBO99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
6/15/2010
66PBO99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Coola Suncare's FDA import refusal history?

Coola Suncare (FEI: 3008144135) has 8 FDA import refusal record(s) in our database, spanning from 6/15/2010 to 6/15/2010.

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. Coola Suncare's FEI number is 3008144135.

What types of violations has Coola Suncare received?

Coola Suncare 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 Coola Suncare come from?

All FDA import refusal data for Coola Suncare 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.