Samba Industrial
⚠️ Moderate Risk
FEI: 3003726364 • Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3003726364
Location
Santo Domingo
Country
DOMINICAN REPUBLICAddress
C/H #6 Villa Marina Los Rios, , 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/10/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53ED05RINSES (HAIR PREPARATIONS, NON-COLORING) | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53ED05RINSES (HAIR PREPARATIONS, NON-COLORING) | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53ED05RINSES (HAIR PREPARATIONS, NON-COLORING) | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 341REGISTERED | San Juan District Office (SJN-DO) |
| 12/10/2003 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 341REGISTERED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Samba Industrial's FDA import refusal history?
Samba Industrial (FEI: 3003726364) has 20 FDA import refusal record(s) in our database, spanning from 12/10/2003 to 12/10/2003.
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. Samba Industrial's FEI number is 3003726364.
What types of violations has Samba Industrial received?
Samba Industrial 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 Samba Industrial come from?
All FDA import refusal data for Samba Industrial 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.