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FG
GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Medical Devices → Snap Diagnostics, LLC.
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Medical Devices FEI: 3000215335 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Snap Diagnostics, LLC.

Registered Address: Illinois, USA (USA)

For Brand Buyers: Snap Diagnostics, LLC. carries a BBB (73/100) rating due to documented FDA activity centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention. Before wiring a deposit, require written proof of CAPA closure and third-party ISO 17025 finished-batch release testing.
Connected FDA Sources (1): FDA ORA FOIA Electronic Reading Room · Resolved Name Aliases: Snap Diagnostics, LLC.
BBB
73/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 47th percentile among Medical Devices facilities.
Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0
Dim 1 · Credit Grade
BBB (73/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
68%
MODERATE CYCLE WINDOW (6–12 Months)
Dim 5 · 180d WL Escalation
42%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
8 Brands
~40 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3000215335's FDA Record

5 Questions to Ask Snap Diagnostics, 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 2026-02-13, FDA cited 21 CFR 812.140(b)(2) (Master Manufacturing & Batch Production Records (MMR/BPR)). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  2. Q2: On 2026-02-13, FDA cited 21 CFR 812.150(a)(1) (Electronic Record Data Integrity (21 CFR Part 11) & Retention). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
  3. Q3: On 2026-02-13, FDA cited 21 CFR 820.130 (Electronic Record Data Integrity (21 CFR Part 11) & Retention). 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 3000215335?

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 · 2026-02-13
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Snap Diagnostics, LLC. (FEI 3000215335) on 2026-02-13 following an inspection of its manufacturer operations in Illinois. The report documents 4 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Electronic Record Data Integrity (21 CFR Part 11) & Retention.

  • 21 CFR 812.140(b)(2) (Master Manufacturing & Batch Production Records (MMR/BPR)): Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
  • 21 CFR 812.150(a)(1) (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.
  • 21 CFR 820.130 (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.
  • 21 CFR 820.30(g) (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.

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) 60/100
Materials & Incoming Identity 74/100
Production & Batch Records 67/100
Facilities, Sanitation & Pest 69/100
Laboratory & Stability Controls 74/100
Packaging & Allergen Labeling 78/100
Layer 6 · Clean-Record Sourcing Alternatives

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Score Provenance Receipts

Every point in this facility's FDA Record Index (73/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-02-13 -8.5 pts INSP-483-3000215335-20260213 ↗
Form 483 (4 observations, 0 repeat) 2026-02-13 -10.2 pts 483-3000215335-20260213 ↗