CC0 PUBLIC RECORD GRAPH Every score & timeline item links directly to its underlying U.S. FDA record (openFDA, ORA FOIA Reading Room, DECRS & OASIS).
Scoring Formula v2.0 & Legal Guardrails REST API v1
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GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Medical Devices → Medtronic Navigation, Inc.
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Medical Devices FEI: FEI-7E35D337 🛡️ LEVEL 0 · PAPER REGISTRATION ONLY

Medtronic Navigation, Inc.

Registered Address: 200 Medtronic Dr, Lafayette, CO (United States)

For Brand Buyers: Medtronic Navigation, Inc. carries a CCC (56/100) rating due to documented FDA activity centered on cGMP documentation controls. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (1): openFDA Enforcement Reports · Resolved Name Aliases: Medtronic Navigation, Inc.
CCC
56/100
Elevated Citations
7-Dim FDA Record Index v2.0
More recent FDA citations than 67% of tracked Medical Devices facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
CCC (56/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 0 / 4
Registered in FDA Database — Zero Physical FDA Inspections Recorded
Dim 4 · 'Elsa' Audit Odds
71%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
4%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
8 Brands
~38 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI FEI-7E35D337's FDA Record

5 Questions to Ask Medtronic Navigation, Inc. Before Signing a Manufacturing Contract

Bring these exact questions to your discovery call with their QA Director or account rep before wiring a production deposit:

  1. Q1: Regarding Recall Z-0197-2027 (Class II on 2026-10-28), what line-clearance or preventive control changes were implemented to prevent recurrence?
  2. Q2: Since FDA databases show an electronic registration without a recorded physical FDA inspection, can you provide your most recent third-party SQF, UL, NSF, or ISO cGMP audit report?
  3. Q3: Do you perform 100% FTIR/HPLC identity testing on incoming active ingredients in-house (21 CFR 111.75(a)(1)), or do you rely on vendor COAs?
  4. Q4: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI FEI-7E35D337?
  5. Q5: Can we review a redacted Master Manufacturing Record (MMR) and Batch Production Record (BPR) with dual-operator weight verification and yield reconciliation?

Cross-Database Regulatory & Inspection Timeline

Unified chronological history across FDA ORA Inspections, Form 483s, Warning Letters, Enforcement Recalls, and OASIS Import Refusals.

FDA Enforcement Recall (Class II · Z-0197-2027) · 2026-10-28
View Recall Notice →
Product: Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly
Reason: Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
FDA Enforcement Recall (Class II · Z-0196-2027) · 2026-10-28
View Recall Notice →
Product: Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly
Reason: Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.
FDA Enforcement Recall (Class II · Z-0194-2027) · 2026-10-28
View Recall Notice →
Product: Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly
Reason: Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.

Manufacturer Right-of-Reply & Free Match Correction

GUARDRAIL PROTECTED

To ensure fairness and accuracy, facility owners may submit verified Form 483 closeout evidence, CAPA completion statements, or entity-resolution corrections free of charge. Sponsorship never alters an FDA Record Index score.

Dimension 3 · FDA 6-System Model

6-Subsystem cGMP Radar Breakdown

Sub-scores mapped across FDA's six core inspection subsystems.

Quality System (CAPA & OOS) 59/100
Materials & Incoming Identity 57/100
Production & Batch Records 58/100
Facilities, Sanitation & Pest 60/100
Laboratory & Stability Controls 57/100
Packaging & Allergen Labeling 61/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (56/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Recall (Class II) 2026-10-28 -12.0 pts Z-0197-2027 ↗
Recall (Class II) 2026-10-28 -12.0 pts Z-0196-2027 ↗
Recall (Class II) 2026-10-28 -12.0 pts Z-0194-2027 ↗