Sabesa De C.V.
⚠️ Moderate Risk
FEI: 3010968818 • San Juan Opico, La Libertad • EL SALVADOR
FEI Number
3010968818
Location
San Juan Opico, La Libertad
Country
EL SALVADORAddress
Km 28.5 Carretera A Santa Ana, , San Juan Opico, La Libertad, El Salvador
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 |
|---|---|---|---|
| 7/8/2016 | 61HBL05ZINC PYRITHIONE (ANTI-BACTERIAL) | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 7/8/2016 | 61HBL05ZINC PYRITHIONE (ANTI-BACTERIAL) | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 7/8/2016 | 61HBL05ZINC PYRITHIONE (ANTI-BACTERIAL) | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Sabesa De C.V.'s FDA import refusal history?
Sabesa De C.V. (FEI: 3010968818) has 3 FDA import refusal record(s) in our database, spanning from 7/8/2016 to 7/8/2016.
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. Sabesa De C.V.'s FEI number is 3010968818.
What types of violations has Sabesa De C.V. received?
Sabesa De C.V. 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 Sabesa De C.V. come from?
All FDA import refusal data for Sabesa De C.V. 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.