{"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","discovered_at":"2026-05-14T18:02:40.340464+00:00","generated_at":"2026-05-16T14:16:57.085977+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Celularity receives FDA warning letter over Interfyl marketing claims","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-25-026383","json":"https://secwatch.observer/filing/0001493152-25-026383.json","markdown":"https://secwatch.observer/filing/0001493152-25-026383.md","text":"https://secwatch.observer/filing/0001493152-25-026383.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T14:16:57.085977+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}