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Miss Key Laboratorio Key C.X A.

⚠️ Moderate Risk

FEI: 3003872823 • Santo Domingo • DOMINICAN REPUBLIC

FEI

FEI Number

3003872823

📍

Location

Santo Domingo

🇩🇴
🏢

Address

Ave Mella, , Santo Domingo, , Dominican Republic

Moderate Risk

FDA Import Risk Assessment

34.6
LowModerateHighCritical

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

Statistics

8
Total Refusals
1
Unique Violations
8/5/2005
Latest Refusal
8/5/2005
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

4718×

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
8/5/2005
53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Baltimore District Office (BLT-DO)
8/5/2005
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Baltimore District Office (BLT-DO)
8/5/2005
53HD05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS)
471CSTIC LBLG
Baltimore District Office (BLT-DO)
8/5/2005
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Baltimore District Office (BLT-DO)
8/5/2005
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Baltimore District Office (BLT-DO)
8/5/2005
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Baltimore District Office (BLT-DO)
8/5/2005
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Baltimore District Office (BLT-DO)
8/5/2005
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Miss Key Laboratorio Key C.X A.'s FDA import refusal history?

Miss Key Laboratorio Key C.X A. (FEI: 3003872823) has 8 FDA import refusal record(s) in our database, spanning from 8/5/2005 to 8/5/2005.

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. Miss Key Laboratorio Key C.X A.'s FEI number is 3003872823.

What types of violations has Miss Key Laboratorio Key C.X A. received?

Miss Key Laboratorio Key C.X A. 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 Miss Key Laboratorio Key C.X A. come from?

All FDA import refusal data for Miss Key Laboratorio Key C.X A. 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.