Form FDA 483 · Issued 2026-03-13
Kibun Foods Inc. Funabasi Factory — FDA Form 483 Analysis
FEI: 3004323569 · Sector: Food & Beverage (Shell Egg Producer) · Lead Investigator: Marcus V. Delgado
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.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 1.506(c)
Supplier Qualification & Foreign Supplier Verification (FSVP)
FIRST-TIME OBSERVATION
Supplier verification assurance
Inspector Observation Language: "Your foreign supplier verification activities did not provide assurance that the hazards requiring a control in the food you import have been significantly minimized or prevented. Specifically, observed during inspection of Kibun Foods Inc. Funabasi Factory on 2026-03-13."
Plain-English Meaning: 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.
Standard CAPA Remediation Path: Maintain an Approved Supplier List (ASL) with hazard analysis, third-party GMP audit certificates, and FSVP importer identification for every foreign ingredient.
Observation #2 · 21 CFR 108.35(c)(3)(i)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Process adherence
Inspector Observation Language: "You did not process each low-acid canned food in conformity with at least the filed scheduled processes and modifications. Specifically, observed during inspection of Kibun Foods Inc. Funabasi Factory on 2026-03-13."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.