Avent S. de R.L. de C.V.
⚠️ Moderate Risk
FEI: 3007596547 • Tijuana, Baja California • MEXICO
FEI Number
3007596547
Location
Tijuana, Baja California
Country
MEXICOAddress
Ave Noruega Edificio D 1b, Fraccionamiento, Rubio, Tijuana, Baja California, Mexico
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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/19/2015 | 78KGEFORCEPS, BIOPSY, ELECTRIC | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 8/4/2015 | 78KDHCATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 8/4/2015 | 78KDHCATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 8/4/2015 | 78FBKNEEDLE, ENDOSCOPIC | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Avent S. de R.L. de C.V.'s FDA import refusal history?
Avent S. de R.L. de C.V. (FEI: 3007596547) has 4 FDA import refusal record(s) in our database, spanning from 8/4/2015 to 8/19/2015.
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. Avent S. de R.L. de C.V.'s FEI number is 3007596547.
What types of violations has Avent S. de R.L. de C.V. received?
Avent S. de R.L. 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 Avent S. de R.L. de C.V. come from?
All FDA import refusal data for Avent S. de R.L. 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.