Form FDA 483 · Issued 2026-02-18
Biomat USA, Incorporated — FDA Form 483 Analysis
FEI: 3003801922 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Source Plasma) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Biomat USA, Incorporated (FEI 3003801922) on 2026-02-18 following an inspection of its source plasma operations in Utah. The report documents 2 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 (2)
Observation #1 · 21 CFR 211.65(a)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Equipment construction - reactive surfaces
Inspector Observation Language: "Equipment surfaces that contact [components] [in-process materials] [drug products] are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. Specifically, observed during inspection of Biomat USA, Incorporated on 2026-02-18."
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(c)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Sampling and testing plans not followed
Inspector Observation Language: "Written procedures for sampling and testing plans are not followed for each drug product. Specifically, observed during inspection of Biomat USA, Incorporated on 2026-02-18."
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.