Issued to ImmunityBio, Inc.. Serious post-market compliance violation.
Issued
March 13, 2026Product
False & Misleading Claims/Misbranded
Company
ImmunityBio, Inc.
Review center
Other
Stage
Final Decision
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FDA issued a warning letter to ImmunityBio, Inc. concerning False & Misleading Claims/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on March 13, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.