Form FDA 483 · Issued 2025-12-23
Smithfield Biosciencs, Inc. — FDA Form 483 Analysis
FEI: 1527761 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Active Pharmaceutical Ingredient Manufacturer) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to Smithfield Biosciencs, Inc. (FEI 1527761) on 2025-12-23 following an inspection of its active pharmaceutical ingredient manufacturer operations in Ohio. The report documents 3 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.80(d)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Status of Each Lot Identified
Inspector Observation Language: "Each lot of [components] [drug product containers] [closures] was not appropriately identified as to its status in terms of being quarantined, approved or rejected. Specifically, observed during inspection of Smithfield Biosciencs, Inc. on 2025-12-23."
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 211.165(d)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Acceptance/Rejection Levels
Inspector Observation Language: "The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels]. Specifically, observed during inspection of Smithfield Biosciencs, Inc. on 2025-12-23."
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 #3 · 21 CFR 314.81(b)(1)(ii)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Contamination, chemical or physical change, deterioration
Inspector Observation Language: "An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning [bacteriological contamination] [significant chemical, physical, or other change or deterioration] in a distributed drug product. Specifically, observed during inspection of Smithfield Biosciencs, Inc. on 2025-12-23."
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.