Form FDA 483 · Issued 2026-02-17
PETNET Solutions Inc — FDA Form 483 Analysis
FEI: 3011121261 · Sector: Food & Beverage (Producer of Regulated Products) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to PETNET Solutions Inc (FEI 3011121261) on 2026-02-17 following an inspection of its producer of regulated products operations in Ohio. The report documents 2 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 111.153
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Written procedures - establish; components
Inspector Observation Language: "You did not establish written procedures for the requirements for [components of dietary supplements] [packaging received] [labels received] [product received for packaging or labeling as a dietary supplement] [rejected components, packaging, or labels] [rejected products that are received for packaging or labeling as a dietary supplement]. Specifically, observed during inspection of PETNET Solutions Inc on 2026-02-17."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #2 · 21 CFR 120.24(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Process controls - HACCP plan - 5 log reduction
Inspector Observation Language: "Your HACCP plan does not include control measures that will consistently produce a 5 log reduction in the most resistant microorganism of public health significance that is likely to occur in the juice, for a period at least as long as the shelf life of the product. Specifically, observed during inspection of PETNET Solutions Inc on 2026-02-17."
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.