Warning letterPosted March 24, 2026
FDA warning letter to ImmunityBio, Inc.
False & Misleading Claims/Misbranded
FDA posted a warning letter to ImmunityBio, Inc. on March 24, 2026; the letter is dated March 13, 2026. Subject: False & Misleading Claims/Misbranded. Issuing office: The Office of Prescription Drug Promotion (OPDP).
On the record
- Company
- ImmunityBio, Inc.
- Subject
- False & Misleading Claims/Misbranded
- Issuing office
- The Office of Prescription Drug Promotion (OPDP)
- Letter dated
- 2026-03-13
- Posted by FDA
- 2026-03-24
- Source
- FDA warning letters ↗
CFR cited
The record cites 3 sections of 21 CFR Parts 201, 202 and 314.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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