---
schema_version: "secwatch.filing_event.v1"
accession: "0000917520-25-000004"
form_type: "8-K"
ticker: "IART"
cik: "0000917520"
company_name: "INTEGRA LIFESCIENCES HOLDINGS CORP"
filed_at: "2025-01-06T23:59:59+00:00"
generated_at: "2026-05-28T12:00:41.655080+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Integra LifeSciences receives FDA warning letter for quality system violations at three facilities

## Summary
- FDA warning letter dated Dec 19, 2024, for quality system issues at Mansfield, MA; Plainsboro, NJ; Princeton, NJ facilities.
- Products cited: cranial perforators, cottonoid patties, strips, collagen-based products; shipping holds and voluntary recall of patties/strips previously initiated.
- Warning letter does not restrict manufacturing/shipment or require recall; premarket approval for related Class III devices blocked until violations resolved.
- Company reaffirms Q4 revenue guidance of $441M-$451M; expects no material impact from warning letter.
- Company is executing a compliance master plan and preparing a written response to the FDA.

## SEC filing metadata
- accession: 0000917520-25-000004
- form_type: 8-K
- ticker: IART
- cik: 0000917520
- company_name: INTEGRA LIFESCIENCES HOLDINGS CORP
- filed_at: 2025-01-06T23:59:59+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/917520/000091752025000004/0000917520-25-000004-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/917520/000091752025000004/iart-20241219.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000917520-25-000004
- JSON: https://secwatch.observer/filing/0000917520-25-000004.json
- Plain text: https://secwatch.observer/filing/0000917520-25-000004.txt

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