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 → Dietary Supplements → Lone Star Nutraceuticals & Gummy Works LLC
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Dietary Supplements FEI: 3014892104 DUNS: 084192831 🛡️ LEVEL 4 · MULTI-CYCLE AUDITED CLEAN (GOLD SHIELD)

Lone Star Nutraceuticals & Gummy Works LLC

Registered Address: 4800 E. Stassney Ln, Suite 200, Austin, TX 78744 (United States)

For Brand Buyers: Lone Star Nutraceuticals & Gummy Works LLC ranks in the top tier (AAA · 99/100) of Dietary Supplements establishments with LEVEL 4 · MULTI-CYCLE AUDITED CLEAN (GOLD SHIELD). Standard quality agreement and lot-by-lot CofA verification apply.
Connected FDA Sources (1): GMPGraph Verified Co-Packer Registry & Inspection Link · Resolved Name Aliases: Lone Star Nutraceuticals & Gummy Works LLC
AAA
99/100
Clean Record
7-Dim FDA Record Index v2.0
Fewer FDA citations than 99% of tracked Dietary Supplements facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
AAA (99/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 4 / 4
Consecutive Clean Physical FDA Inspections (NAI)
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
23 Brands
~94 Downstream SKUs
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VERIFIED CONTRACT MANUFACTURER / CO-PACKER AI MOCK-INSPECTION READINESS BADGE SPONSORED PLACEMENT (SCORE UNALTERED)

Co-Packing Capabilities, Minimums & Certifications

Request Quote from Lone Star Nutraceuticals & Gummy Works LLC →

Supplement & functional wellness brands scaling pectin gummies, pre-workout/electrolyte powders, and capsule lines.

Minimum Run (MOQ)5,000 units
Typical Turnaround6–8 weeks
In-House Analytical LabYes (FTIR/HPLC/Micro)
Turnkey R&D FormulationAvailable
Dosage & Product Formats:
Pectin & Gelatin GummiesTwo-Piece Hard CapsulesStick Packs & Hydration PowdersLiquid Tinctures
Registrations & Quality Certifications:
21 CFR Part 111 cGMP VerifiedNSF Certified for SportUSDA OrganicKosherHalal
LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3014892104's FDA Record

5 Questions to Ask Lone Star Nutraceuticals & Gummy Works 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: 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 3014892104?
  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 · 2026-04-12
Project Area: Dietary Supplements · Lead Investigator: Marcus V. Delgado
FDA Inspection Classification: NAI · 2024-08-21
Project Area: Dietary Supplements · 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 99/100
Production & Batch Records 99/100
Facilities, Sanitation & Pest 99/100
Laboratory & Stability Controls 99/100
Packaging & Allergen Labeling 99/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (99/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Clean Inspection (NAI) 2026-04-12 +4.4 pts INSP-3014892104-20260412 ↗
Clean Inspection (NAI) 2024-08-21 +3.0 pts INSP-3014892104-20240821 ↗