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 → Ventec Life Systems, Inc.
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Medical Devices FEI: FEI-DB14376C 🛡️ LEVEL 0 · PAPER REGISTRATION ONLY

Ventec Life Systems, Inc.

Registered Address: 22002 26th Ave Se, Bothell, WA (United States)

For Brand Buyers: Ventec Life Systems, Inc. carries a CCC (17/100) 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: Ventec Life Systems, Inc.
CCC
17/100
Elevated Citations
7-Dim FDA Record Index v2.0
More recent FDA citations than 87% 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 (17/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 0 / 4
Registered in FDA Database — Zero Physical FDA Inspections Recorded
Dim 4 · 'Elsa' Audit Odds
70%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
4%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
7 Brands
~33 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI FEI-DB14376C's FDA Record

5 Questions to Ask Ventec Life Systems, 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-0127-2027 (Class I 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-DB14376C?
  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 I · Z-0127-2027) · 2026-10-28
View Recall Notice →
Product: VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.
Reason: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
FDA Enforcement Recall (Class I · Z-0132-2027) · 2026-10-28
View Recall Notice →
Product: V+ Pro Emergency, Model Number: PRT-01201-000, Package PN:PRT-01173-000,PRT-01222-000. used for ventilatory support.
Reason: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.
FDA Enforcement Recall (Class I · Z-0131-2027) · 2026-10-28
View Recall Notice →
Product: VC(Japan) Model Number: PRT-01098-100, Package PN:PRT-01125-100. used for ventilatory support.
Reason: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.

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) 20/100
Materials & Incoming Identity 18/100
Production & Batch Records 19/100
Facilities, Sanitation & Pest 21/100
Laboratory & Stability Controls 18/100
Packaging & Allergen Labeling 22/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (17/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Recall (Class I) 2026-10-28 -24.9 pts Z-0127-2027 ↗
Recall (Class I) 2026-10-28 -24.9 pts Z-0132-2027 ↗
Recall (Class I) 2026-10-28 -24.9 pts Z-0131-2027 ↗