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 → STAQ Pharma of Ohio LLC
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3025336457 🛡️ LEVEL 1 · ACTIVE REMEDIATION REQUIRED

STAQ Pharma of Ohio LLC

Registered Address: Ohio, United States (United States)

For Brand Buyers: STAQ Pharma of Ohio LLC carries a CCC (41/100) rating due to documented FDA activity centered on Cleaning Validation, Sanitation Logs & Pest Control. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (2): FDA ORA FOIA Electronic Reading Room, FDA Warning Letters Archive · Resolved Name Aliases: STAQ Pharma of Ohio LLC
CCC
41/100
Elevated Citations
7-Dim FDA Record Index v2.0
More recent FDA citations than 96% 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 (41/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 1 / 4
Official Action Indicated (OAI) or Open Warning Letter
Dim 4 · 'Elsa' Audit Odds
89%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
92%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
10 Brands
~47 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3025336457's FDA Record

5 Questions to Ask STAQ Pharma of Ohio 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: On 2026-08-19, FDA cited 21 CFR 211.67(b) (Cleaning Validation, Sanitation Logs & Pest Control). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  2. Q2: On 2026-08-19, FDA cited 21 CFR 211.68(a) (Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  3. Q3: On 2026-08-19, FDA cited 21 CFR 211.166(a) (Finished Product Testing, Stability & Expiration Dating). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  4. Q4: 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?
  5. Q5: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 3025336457?

Cross-Database Regulatory & Inspection Timeline

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

Form FDA 483 Issued · 2026-08-19
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to STAQ Pharma of Ohio LLC (FEI 3025336457) on 2026-08-19 following an inspection of its outsourcing facility operations in Ohio. The report documents 5 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.

  • 21 CFR 211.67(b) (Cleaning Validation, Sanitation Logs & Pest Control): Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
  • 21 CFR 211.68(a) (Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems): Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
  • 21 CFR 211.166(a) (Finished Product Testing, Stability & Expiration Dating): Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
  • 21 CFR 211.84(d)(1) (Incoming Ingredient Identity Testing & COA Qualification): Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier. REPEAT OBSERVATION
  • 21 CFR 211.22(a) (Electronic Record Data Integrity (21 CFR Part 11) & Retention): Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
FDA Warning Letter (CMS-684107) · 2025-12-10
View Warning Letter Details →
CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.67(b), 21 CFR 211.68(a)) — Status: Open — Awaiting Verified Remediation Closeout

FDA Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.

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) 36/100
Materials & Incoming Identity 28/100
Production & Batch Records 43/100
Facilities, Sanitation & Pest 29/100
Laboratory & Stability Controls 34/100
Packaging & Allergen Labeling 46/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (41/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-08-19 -9.5 pts INSP-483-3025336457-20260819 ↗
Form 483 (5 observations, 1 repeat) 2026-08-19 -17.2 pts 483-3025336457-20260819 ↗
Warning Letter (Open) 2025-12-10 -24.4 pts CMS-684107 ↗