Warning letterPosted August 26, 2025
FDA warning letter to Innate Healthcare Institute
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
FDA posted a warning letter to Innate Healthcare Institute on August 26, 2025; the letter is dated August 15, 2025. Subject: Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps). Issuing office: Center for Biologics Evaluation and Research (CBER).
On the record
- Company
- Innate Healthcare Institute
- Subject
- Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
- Issuing office
- Center for Biologics Evaluation and Research (CBER)
- Letter dated
- 2025-08-15
- Posted by FDA
- 2025-08-26
- Source
- FDA warning letters ↗
CFR cited
The record cites 5 sections of 21 CFR Parts 201 and 1271.
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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