Form FDA 483 · Issued 2026-03-06
PETNET Solutions, Inc. — FDA Form 483 Analysis
FEI: 3009856092 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Pet Drug Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to PETNET Solutions, Inc. (FEI 3009856092) on 2026-03-06 following an inspection of its pet drug manufacturer operations in Nevada. The report documents 2 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.194(c)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Testing and standardization of standards et. al.
Inspector Observation Language: "Laboratory records do not include complete records of any testing and standardization of laboratory [reference standards] [reagents] [standard solutions]. Specifically, observed during inspection of PETNET Solutions, Inc. on 2026-03-06."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
Observation #2 · 21 CFR 211.165(d)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Acceptance criteria for sampling & testing
Inspector Observation Language: "Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet [each appropriate specification] [appropriate statistical quality control criteria] as a condition for their approval and release. Specifically, observed during inspection of PETNET Solutions, Inc. on 2026-03-06."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.