Form FDA 483 · Issued 2026-03-20
2seventy bio, Inc. — FDA Form 483 Analysis
FEI: 3013427685 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Viral Vector Testing Lab) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to 2seventy bio, Inc. (FEI 3013427685) on 2026-03-20 following an inspection of its viral vector testing lab operations in Massachusetts. The report documents 2 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 (2)
Observation #1 · 21 CFR 211.160(a)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Lab controls established, including changes
Inspector Observation Language: "The establishment of [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] including any changes thereto, are not [drafted by the appropriate organizational unit] [reviewed and approved by the quality control unit]. Specifically, observed during inspection of 2seventy bio, Inc. on 2026-03-20."
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
Backup data not assured as exact and complete
Inspector Observation Language: "Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems. Specifically, observed during inspection of 2seventy bio, Inc. on 2026-03-20."
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.