Facility Graph → Food & Beverage → Kibun Foods Inc. Funabasi Factory

INDEXABLE (PASSES DATA-SUFFICIENCY GATE)

Food & Beverage FEI: 3004323569 🛡️ LEVEL 2 · VAI OBSERVATION FOLLOW-UP

Kibun Foods Inc. Funabasi Factory

Registered Address: Japan (Japan)

For Brand Buyers: Kibun Foods Inc. Funabasi Factory carries a BBB (78/100) rating due to documented FDA activity centered on Supplier Qualification & Foreign Supplier Verification (FSVP). 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: Kibun Foods Inc. Funabasi Factory

BBB

78/100

Moderate (VAI)

7-Dim FDA Record Index v2.0

Ranks in the 54th percentile among Food & Beverage facilities.

Based strictly on public U.S. FDA records as of 2026-11-03. See Formula v2.0

Dim 1 · Credit Grade

BBB (78/100)

Recency-Weighted Index

Dim 2 · Inspection Shield

Level 2 / 4

Physically Inspected — Documented Form 483 Observations

Dim 4 · 'Elsa' Audit Odds

69%

MODERATE CYCLE WINDOW (6–12 Months)

Dim 5 · 180d WL Escalation

30%

483 → Warning Letter Risk

Dim 6 · Brand Contagion

7 Brands

~36 Downstream SKUs

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LAYER 4 · AI BUYER DUE-DILIGENCE INTERVIEW SCRIPT Tailored to FEI 3004323569's FDA Record

5 Questions to Ask Kibun Foods Inc. Funabasi Factory 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:

Q1: On 2026-03-13, FDA cited 21 CFR 1.506(c) (Supplier Qualification & Foreign Supplier Verification (FSVP)). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
Q2: On 2026-03-13, FDA cited 21 CFR 108.35(c)(3)(i) (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?
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?
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 3004323569?
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 · 2026-03-13

Open Full 483 Analysis & Dossier →

FDA Form 483 issued to Kibun Foods Inc. Funabasi Factory (FEI 3004323569) on 2026-03-13 following an inspection of its shell egg producer operations in Japan. The report documents 2 inspection observations centered on Supplier Qualification & Foreign Supplier Verification (FSVP), Electronic Record Data Integrity (21 CFR Part 11) & Retention.

21 CFR 1.506(c) (Supplier Qualification & Foreign Supplier Verification (FSVP)): Failure to develop or maintain a Foreign Supplier Verification Program (FSVP) or approved vendor qualification file verifying that raw material suppliers meet U.S. FDA safety standards.
21 CFR 108.35(c)(3)(i) (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.

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) 73/100

Materials & Incoming Identity 71/100

Production & Batch Records 80/100

Facilities, Sanitation & Pest 82/100

Laboratory & Stability Controls 79/100

Packaging & Allergen Labeling 83/100

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