BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V.
⚠️ Moderate Risk
FEI: 3002879021 • Nogales, Sonora • MEXICO
FEI Number
3002879021
Location
Nogales, Sonora
Country
MEXICOAddress
Callejon Luis Donaldo Colosio # 579, Col. J. Kalitea, Nogales, Sonora, 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.
STAINSTEEL
The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/22/2019 | 80FMFSYRINGE, PISTON | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 8/1/2018 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 1/12/2012 | 80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V.'s FDA import refusal history?
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V. (FEI: 3002879021) has 3 FDA import refusal record(s) in our database, spanning from 1/12/2012 to 3/22/2019.
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. BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V.'s FEI number is 3002879021.
What types of violations has BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V. received?
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V. has been cited for 2 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 BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V. come from?
All FDA import refusal data for BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. 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.