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
FG
GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Medical Devices → Precision MedTech Sterile Contract Assembly Inc.
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Medical Devices FEI: 3009841276 DUNS: 049182736 🛡️ LEVEL 4 · MULTI-CYCLE AUDITED CLEAN (GOLD SHIELD)

Precision MedTech Sterile Contract Assembly Inc.

Registered Address: 9800 Metric Blvd, Minneapolis, MN 55434 (United States)

For Brand Buyers: Precision MedTech Sterile Contract Assembly Inc. ranks in the top tier (AAA · 99/100) of Medical Devices establishments with LEVEL 4 · MULTI-CYCLE AUDITED CLEAN (GOLD SHIELD). Standard quality agreement and lot-by-lot CofA verification apply.
Connected FDA Sources (1): GMPGraph Verified Co-Packer Registry & Inspection Link · Resolved Name Aliases: Precision MedTech Sterile Contract Assembly Inc.
AAA
99/100
Clean Record
7-Dim FDA Record Index v2.0
Fewer FDA citations than 99% 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
AAA (99/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 4 / 4
Consecutive Clean Physical FDA Inspections (NAI)
Dim 4 · 'Elsa' Audit Odds
22%
LOW IMMEDIATE AUDIT PROBABILITY (Routine Cycle)
Dim 5 · 180d WL Escalation
4%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
30 Brands
~129 Downstream SKUs
🛡️ Run AI Mock Inspection on This Plant ⚖️ Compare Side-by-Side vs. Clean Co-Packers 📄 Request EIR via FOIA
Represent this facility? Claim profile or post 483 closeout response (Free)
VERIFIED CONTRACT MANUFACTURER / CO-PACKER AI MOCK-INSPECTION READINESS BADGE

Co-Packing Capabilities, Minimums & Certifications

Request Quote from Precision MedTech Sterile Contract Assembly Inc. →

510(k) device founders and diagnostic companies needing an ISO 13485 contract manufacturer with clean FDA inspection history.

Minimum Run (MOQ)1,000 units
Typical Turnaround8–12 weeks
In-House Analytical LabYes (FTIR/HPLC/Micro)
Turnkey R&D FormulationCustomer Formula Only
Dosage & Product Formats:
Class I & Class II Medical DevicesISO Class 7 Cleanroom Molding & PackagingDiagnostic Point-of-Care CassettesEO & Gamma Sterilization Management
Registrations & Quality Certifications:
FDA 21 CFR Part 820 / QMSRISO 13485:2016 CertifiedMDSAP Audited
LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3009841276's FDA Record

5 Questions to Ask Precision MedTech Sterile Contract Assembly 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: 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?
  2. Q2: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 3009841276?
  3. Q3: Can we review a redacted Master Manufacturing Record (MMR) and Batch Production Record (BPR) with dual-operator weight verification and yield reconciliation?
  4. Q4: What is your current quarantined finished-product release turnaround for USP microbial limits (<2021>/<2022>) and heavy metals (<2232>)?

Cross-Database Regulatory & Inspection Timeline

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

FDA Inspection Classification: NAI · 2026-05-04
Project Area: Medical Devices · Lead Investigator: Marcus V. Delgado
FDA Inspection Classification: NAI · 2024-07-12
Project Area: Medical Devices · Lead Investigator: Marcus V. Delgado

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) 99/100
Materials & Incoming Identity 99/100
Production & Batch Records 99/100
Facilities, Sanitation & Pest 99/100
Laboratory & Stability Controls 99/100
Packaging & Allergen Labeling 99/100
Layer 6 · Clean-Record Sourcing Alternatives

Verified AAA/AA Co-Packers in This Sector

Compare or request quotes from top-rated contract manufacturers with clean FDA inspection histories:

Score Provenance Receipts

Every point in this facility's FDA Record Index (99/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Clean Inspection (NAI) 2026-05-04 +4.5 pts INSP-3009841276-20260504 ↗
Clean Inspection (NAI) 2024-07-12 +2.9 pts INSP-3009841276-20240712 ↗