Form FDA 483 · Issued 2026-03-05
Farmina Pet Food USA LLC — FDA Form 483 Analysis
FEI: 3025523697 · Sector: Food & Beverage (Pet Food Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Farmina Pet Food USA LLC (FEI 3025523697) on 2026-03-05 following an inspection of its pet food manufacturer operations in North Carolina. The report documents 2 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 114.80(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Quality control procedures
Inspector Observation Language: "Appropriate quality control procedures are not employed to ensure that finished foods do not present a health hazard. Specifically, "observed during inspection of Farmina Pet Food USA LLC on 2026-03-05."
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.
Observation #2 · 21 CFR 117.305
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Preventive controls records - General requirements
Inspector Observation Language: "Your preventive controls records did not meet general records requirements. Specifically, observed during inspection of Farmina Pet Food USA LLC on 2026-03-05."
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.