Form FDA 483 · Issued 2026-01-12
Biomat USA Inc — FDA Form 483 Analysis
FEI: 3022988848 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Source Plasma) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to Biomat USA Inc (FEI 3022988848) on 2026-01-12 following an inspection of its source plasma operations in Ohio. The report documents 3 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.160(a)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Deviations from laboratory control requirements
Inspector Observation Language: "Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified]. Specifically, observed during inspection of Biomat USA Inc on 2026-01-12."
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 211.68(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Written record not kept of program and validation data
Inspector Observation Language: "A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes. Specifically, observed during inspection of Biomat USA Inc on 2026-01-12."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.
Observation #3 · 21 CFR 211.160(b)(2)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
In-process samples representative, identified properly
Inspector Observation Language: "Samples taken of in-process materials for determination of conformance to specifications are not [representative] [properly identified]. Specifically, observed during inspection of Biomat USA Inc on 2026-01-12."
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.