Form FDA 483 · Issued 2026-05-12
Richmond VA Medical Center — FDA Form 483 Analysis
FEI: 1174302 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Sterile Drug Products) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to Richmond VA Medical Center (FEI 1174302) on 2026-05-12 following an inspection of its producer of sterile drug products operations in Virginia. The report documents 3 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.165(b)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Microbiological testing
Inspector Observation Language: "Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Specifically, observed during inspection of Richmond VA Medical Center on 2026-05-12."
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.
Observation #2 · 21 CFR 211.166(a)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Written program not followed
Inspector Observation Language: "The written stability testing program is not followed. Specifically, observed during inspection of Richmond VA Medical Center on 2026-05-12."
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 #3 · 21 CFR 211.160(a)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Following/documenting laboratory controls
Inspector Observation Language: "Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance]. Specifically, observed during inspection of Richmond VA Medical Center on 2026-05-12."
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.