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 → Pharmaceuticals & Sterile/OTC Drugs → Par Health USA, LLC
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: FEI-71346721 🛡️ LEVEL 0 · PAPER REGISTRATION ONLY

Par Health USA, LLC

Registered Address: 870 Parkdale Rd, Rochester, MI (United States)

For Brand Buyers: Par Health USA, LLC carries a CCC (42/100) 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: Par Health USA, LLC
CCC
42/100
Elevated Citations
7-Dim FDA Record Index v2.0
More recent FDA citations than 95% 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
CCC (42/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 0 / 4
Registered in FDA Database — Zero Physical FDA Inspections Recorded
Dim 4 · 'Elsa' Audit Odds
75%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
4%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
6 Brands
~30 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI FEI-71346721's FDA Record

5 Questions to Ask Par Health USA, LLC 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-0082-2027 (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-71346721?
  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 · D-0082-2027) · 2026-10-28
View Recall Notice →
Product: Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10
Reason: Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.
FDA Enforcement Recall (Class I · D-0083-2027) · 2026-10-28
View Recall Notice →
Product: Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/ Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Cranbury, NJ 08512, N
Reason: Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.

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) 45/100
Materials & Incoming Identity 43/100
Production & Batch Records 44/100
Facilities, Sanitation & Pest 46/100
Laboratory & Stability Controls 43/100
Packaging & Allergen Labeling 47/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (42/100) 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 D-0082-2027 ↗
Recall (Class I) 2026-10-28 -24.9 pts D-0083-2027 ↗