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 → Greiner Bio-One North America, Inc.
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Medical Devices FEI: FEI-0C50B4FA 🛡️ LEVEL 0 · PAPER REGISTRATION ONLY

Greiner Bio-One North America, Inc.

Registered Address: 4238 Capital Dr, Monroe, NC (United States)

For Brand Buyers: Greiner Bio-One North America, Inc. carries a A (80/100) 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: Greiner Bio-One North America, Inc.
A
80/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 93th percentile among Medical Devices facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
A (80/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 0 / 4
Registered in FDA Database — Zero Physical FDA Inspections Recorded
Dim 4 · 'Elsa' Audit Odds
73%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
4%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
10 Brands
~48 Downstream SKUs
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Represent this facility? Claim profile or post 483 closeout response (Free)
LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI FEI-0C50B4FA's FDA Record

5 Questions to Ask Greiner Bio-One North America, 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-0200-2027 (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-0C50B4FA?
  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-0200-2027) · 2026-10-28
View Recall Notice →
Product: Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 75 mm, 3.5ml)
Reason: Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyperkalemia.

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) 83/100
Materials & Incoming Identity 81/100
Production & Batch Records 82/100
Facilities, Sanitation & Pest 84/100
Laboratory & Stability Controls 81/100
Packaging & Allergen Labeling 85/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (80/100) 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-0200-2027 ↗