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 → Pharmaceuticals & Sterile/OTC Drugs → Viatris, Inc.
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Pharmaceuticals & Sterile/OTC Drugs FEI: FEI-6F145D5E 🛡️ LEVEL 0 · PAPER REGISTRATION ONLY

Viatris, Inc.

Registered Address: 3711 Collins Ferry Rd, Morgantown, WV (United States)

For Brand Buyers: Viatris, Inc. ranks in the top tier (AA · 88/100) of Pharmaceuticals & Sterile/OTC Drugs establishments with LEVEL 0 · PAPER REGISTRATION ONLY. Standard quality agreement and lot-by-lot CofA verification apply.
Connected FDA Sources (1): openFDA Enforcement Reports · Resolved Name Aliases: Viatris, Inc.
AA
88/100
Clean Record
7-Dim FDA Record Index v2.0
Fewer FDA citations than 73% of tracked Pharmaceuticals & Sterile/OTC Drugs facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
AA (88/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 0 / 4
Registered in FDA Database — Zero Physical FDA Inspections Recorded
Dim 4 · 'Elsa' Audit Odds
79%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
4%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
10 Brands
~50 Downstream SKUs
🛡️ Run AI Mock Inspection on This Plant ⚖️ Compare Side-by-Side vs. Clean Co-Packers 📄 Request EIR via FOIA
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI FEI-6F145D5E's FDA Record

5 Questions to Ask Viatris, 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 D-0049-2027 (Class III 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-6F145D5E?
  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 III · D-0049-2027) · 2026-10-28
View Recall Notice →
Product: Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA, Made in India, NDC 0378-1075-93.
Reason: Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications

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) 91/100
Materials & Incoming Identity 89/100
Production & Batch Records 90/100
Facilities, Sanitation & Pest 92/100
Laboratory & Stability Controls 89/100
Packaging & Allergen Labeling 93/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (88/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Recall (Class III) 2026-10-28 -4.0 pts D-0049-2027 ↗