Laboratorios Key, Cxa
⚠️ Moderate Risk
FEI: 3003837503 • Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3003837503
Location
Santo Domingo
Country
DOMINICAN REPUBLICAddress
Calle 24, , Santo Domingo, , Dominican Republic
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
| 8/5/2005 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Laboratorios Key, Cxa's FDA import refusal history?
Laboratorios Key, Cxa (FEI: 3003837503) has 17 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. Laboratorios Key, Cxa's FEI number is 3003837503.
What types of violations has Laboratorios Key, Cxa received?
Laboratorios Key, Cxa 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 Laboratorios Key, Cxa come from?
All FDA import refusal data for Laboratorios Key, Cxa 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.