Warning letterPosted July 1, 2025
FDA warning letter to InVia Fertility Specialists, PLLC
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
FDA posted a warning letter to InVia Fertility Specialists, PLLC on July 1, 2025; the letter is dated June 13, 2025. Subject: Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps). Issuing office: Center for Biologics Evaluation and Research.
On the record
- Company
- InVia Fertility Specialists, PLLC
- Subject
- Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
- Issuing office
- Center for Biologics Evaluation and Research
- Letter dated
- 2025-06-13
- Posted by FDA
- 2025-07-01
- Source
- FDA warning letters ↗
CFR cited
The record cites 10 sections of 21 CFR Part 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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