Laboratorios Carolina Srl
⚠️ Moderate Risk
FEI: 3009009178 • Santo Domingo De Guzman, Distrito Nacional • DOMINICAN REPUBLIC
FEI Number
3009009178
Location
Santo Domingo De Guzman, Distrito Nacional
Country
DOMINICAN REPUBLICAddress
Antonio Lizardo Calles Alpesno 47 Urb, , Santo Domingo De Guzman, Distrito Nacional, 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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/29/2013 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/29/2013 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/29/2013 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/29/2013 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/29/2013 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/29/2013 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Laboratorios Carolina Srl's FDA import refusal history?
Laboratorios Carolina Srl (FEI: 3009009178) has 6 FDA import refusal record(s) in our database, spanning from 8/29/2013 to 8/29/2013.
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 Carolina Srl's FEI number is 3009009178.
What types of violations has Laboratorios Carolina Srl received?
Laboratorios Carolina Srl 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 Carolina Srl come from?
All FDA import refusal data for Laboratorios Carolina Srl 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.