MEDTRONIC PUERTO RICO INC.
⚠️ Moderate Risk
FEI: 3013134486 • Villalba, PR • UNITED STATES
FEI Number
3013134486
Location
Villalba, PR
Country
UNITED STATESAddress
Carr 149 Km 56.3, , Villalba, PR, United States
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/29/2017 | 80LKKPUMP, INFUSION, IMPLANTED, PROGRAMMABLE | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/29/2017 | 84LGWSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/29/2017 | 84GZBSTIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/29/2017 | 84MHYSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MEDTRONIC PUERTO RICO INC.'s FDA import refusal history?
MEDTRONIC PUERTO RICO INC. (FEI: 3013134486) has 4 FDA import refusal record(s) in our database, spanning from 8/29/2017 to 8/29/2017.
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. MEDTRONIC PUERTO RICO INC.'s FEI number is 3013134486.
What types of violations has MEDTRONIC PUERTO RICO INC. received?
MEDTRONIC PUERTO RICO INC. 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 MEDTRONIC PUERTO RICO INC. come from?
All FDA import refusal data for MEDTRONIC PUERTO RICO INC. 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.