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GMPGraphv2.0
Global FDA Facility Graph & Co-Packer Intelligence
Facility Graph → Pharmaceuticals & Sterile/OTC Drugs → Biomat USA Inc
INDEXABLE (PASSES DATA-SUFFICIENCY GATE)
Pharmaceuticals & Sterile/OTC Drugs FEI: 3014028128 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Biomat USA Inc

Registered Address: Texas, USA (USA)

For Brand Buyers: Biomat USA Inc carries a BBB (71/100) 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 (2): FDA ORA FOIA Electronic Reading Room, FDA OASIS Import Refusals · Resolved Name Aliases: Biomat USA Inc
BBB
71/100
Moderate (VAI)
7-Dim FDA Record Index v2.0
Ranks in the 40th percentile among 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
BBB (71/100)
Recency-Weighted Index
Dim 2 · Inspection Shield
Level 2 / 4
Physically Inspected — Documented Form 483 Observations
Dim 4 · 'Elsa' Audit Odds
73%
HIGH PRIORITY TARGET (Next 90–180 Days)
Dim 5 · 180d WL Escalation
30%
483 → Warning Letter Risk
Dim 6 · Brand Contagion
5 Brands
~23 Downstream SKUs
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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3014028128's FDA Record

5 Questions to Ask Biomat USA Inc 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 2026-04-14, FDA cited 21 CFR 212.20(e) (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?
  2. Q2: On 2026-04-14, FDA cited 21 CFR 211.22(a) (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: 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 3014028128?
  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.

Form FDA 483 Issued · 2026-04-14
Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Biomat USA Inc (FEI 3014028128) on 2026-04-14 following an inspection of its source plasma establishment operations in Texas. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention.

  • 21 CFR 212.20(e) (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 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.
OASIS Border Import Refusal (OASIS-2026-88118) · 2026-01-19
Port: Savannah, GA · Charge: MISBRANDED COSMETIC / COLOR ADDITIVE (FD&C Act 601(e))
The cosmetic product appears to bear or contain an unlisted color additive or lacks mandatory MoCRA responsible person labeling.

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) 58/100
Materials & Incoming Identity 72/100
Production & Batch Records 73/100
Facilities, Sanitation & Pest 75/100
Laboratory & Stability Controls 72/100
Packaging & Allergen Labeling 76/100
Layer 6 · Clean-Record Sourcing Alternatives

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Lone Star Nutraceuticals & Gummy Works LLC (TX)
Grade AAA · 99/100 Clean Record
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Score Provenance Receipts

Every point in this facility's FDA Record Index (71/100) is backed by a linked government record (36-month half-life decay).

Event Date Weight Receipt
Inspection Outcome (VAI) 2026-04-14 -8.8 pts INSP-483-3014028128-20260414 ↗
Form 483 (2 observations, 0 repeat) 2026-04-14 -5.3 pts 483-3014028128-20260414 ↗
Import Refusal (MISBRANDED COSMETIC / COLOR ADDITIVE) 2026-01-19 -6.7 pts OASIS-2026-88118 ↗