---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-25-026383"
form_type: "8-K"
ticker: "CELU"
cik: "0001752828"
company_name: "Celularity Inc"
filed_at: "2025-12-05T23:59:59+00:00"
generated_at: "2026-05-16T14:16:57.085977+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Celularity receives FDA warning letter over Interfyl marketing claims

## Summary
- FDA warning letter received Dec 1, 2025, regarding marketing material for Interfyl (human connective tissue matrix).
- Letter cites outcome-based and metabolic activity claims; company must limit such claims per Section 361 of CFR 1271.10.
- No restriction on manufacturing, product shipment, recall, or ability to seek 510(k) clearance.
- Company states no material impact on operational/financial expectations; resolution timeline uncertain.
- Additional regulatory action may occur if issues not resolved to FDA's satisfaction.

## SEC filing metadata
- accession: 0001493152-25-026383
- form_type: 8-K
- ticker: CELU
- cik: 0001752828
- company_name: Celularity Inc
- filed_at: 2025-12-05T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1752828/000149315225026383/0001493152-25-026383-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1752828/000149315225026383/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-25-026383
- JSON: https://secwatch.observer/filing/0001493152-25-026383.json
- Plain text: https://secwatch.observer/filing/0001493152-25-026383.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.