Form FDA 483 · Issued 2026-03-19
PETNET Solutions Inc — FDA Form 483 Analysis
FEI: 3008769593 · Sector: Food & Beverage (Manufacturer) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to PETNET Solutions Inc (FEI 3008769593) on 2026-03-19 following an inspection of its manufacturer operations in Alabama. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Cleaning Validation, Sanitation Logs & Pest Control.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 123.6(c)(5)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Corrective action plan
Inspector Observation Language: "Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to ensure [affected product is not entered into commerce] [the cause of the deviation was corrected]. Specificallyobserved during inspection of PETNET Solutions Inc on 2026-03-19."
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 117.35(b)(2)
Cleaning Validation, Sanitation Logs & Pest Control
REPEAT CITATION AT FACILITY
Toxic chemicals - Identified, held, stored
Inspector Observation Language: "You did not [identify] [hold] [store] a toxic chemical in a manner that protects against contamination. Specifically, observed during inspection of PETNET Solutions Inc on 2026-03-19."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
Observation #3 · 21 CFR 108.25(c)(1)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Registration
Inspector Observation Language: "You did not register and file Form FDA 2541 (food canning establishment registration) with FDA within 10 days after first engaging in the manufacture, processing and packaging of acidified foods. Specifically, observed during inspection of PETNET Solutions Inc on 2026-03-19."
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 #4 · 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 PETNET Solutions Inc on 2026-03-19."
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 #5 · 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 PETNET Solutions Inc on 2026-03-19."
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.