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 → Kleen Test Products Corporation
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Pharmaceuticals & Sterile/OTC Drugs FEI: 0001526481 DUNS: 006677816 🛡️ LEVEL 3 · INSPECTED & ACCEPTABLE (EMERALD SHIELD)

Kleen Test Products Corporation

Registered Address: 216 12th Street NE, Strasburg, Ohio (OH) 44680, United States (USA) (United States)

For Brand Buyers: Kleen Test Products Corporation ranks in the top tier (AAA · 96/100) of Pharmaceuticals & Sterile/OTC Drugs establishments with LEVEL 3 · INSPECTED & ACCEPTABLE (EMERALD SHIELD). Standard quality agreement and lot-by-lot CofA verification apply.
Connected FDA Sources (1): FDA DECRS Drug Establishments Registry · Resolved Name Aliases: Kleen Test Products Corporation
AAA
96/100
Clean Record
7-Dim FDA Record Index v2.0
Fewer FDA citations than 99% 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
AAA (96/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 3 / 4
Physically Inspected by FDA — Acceptable Compliance Posture
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
7 Brands
~31 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)
LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 0001526481's FDA Record

5 Questions to Ask Kleen Test Products Corporation 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 0001526481?
  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 · 2025-11-18
Project Area: Drug Quality Assurance (cGMP) · 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 97/100
Production & Batch Records 98/100
Facilities, Sanitation & Pest 99/100
Laboratory & Stability Controls 97/100
Packaging & Allergen Labeling 99/100
Layer 6 · Clean-Record Sourcing Alternatives

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Grade AAA · 99/100 Clean Record
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Score Provenance Receipts

Every point in this facility's FDA Record Index (96/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Clean Inspection (NAI) 2025-11-18 +4.0 pts INSP-NAI-0001526481 ↗