FDA WARNING_LETTER - Integra LifeSciences Corporation - August 22, 2024

The FDA issued a Warning Letter to Integra LifeSciences following inspections at its Mansfield, MA, Plainsboro, NJ, and Princeton, NJ facilities. The firm's neurological and neurosurgical devices were deemed adulterated under 21 U.S.C. § 351(h) due to widespread non-compliance with the Quality System regulation (21 CFR Part 820). Key violations include failures in controlling nonconforming product (21 CFR § 820.90(a)), with inadequate OOS endotoxin investigations and product recalls. Deficiencies were noted in procedures for acceptance activities (21 CFR § 820.80(a)) and finished device acceptance (21 CFR § 820.80(d)), involving unjustified retesting and insufficient pyrogen testing. The corrective and preventive action (CAPA) system (21 CFR § 820.100(a)) was inadequate, with unescalated CAPAs and improper use of quality plans. The firm also failed to review process changes and perform revalidation (21 CFR § 820.75(c)), affecting sterilization and supplier changes. Contamination control (21 CFR § 820.70(e)) was deficient, and critical processes like LAL testing lacked proper validation (21 CFR § 820.75(a)). While Integra initiated CAPAs and recalls, their adequacy is undetermined, with many actions pending into 2025. The FDA demands a comprehensive response within 15 business days addressing systemic issues, warning of potential regulatory actions, including seizure, injunctions, and impacts on device approvals and contracts.