# FDA WARNING_LETTER - Integra LifeSciences Corporation - August 22, 2024

Source: https://www.globalkeysolutions.net/records/warning_letter/integra-lifesciences-corporation/ad10acef-4212-455a-b328-1da9842de1d6

> FDA WARNING_LETTER for Integra LifeSciences Corporation on August 22, 2024. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Integra LifeSciences Corporation
- Inspection Date: 2024-08-22
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: 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.

## Related Documents

- [483 - 2018-07-02](https://www.globalkeysolutions.net/records/483/integra-lifesciences-corporation/38a41c9f-5f70-400a-a156-1ff227e3ccee)
- [WARNING_LETTER - 2023-05-17](https://www.globalkeysolutions.net/records/warning_letter/integra-lifesciences-corporation/b6055000-b7f5-4d2d-bef9-c5cebd9b5863)

## Related Officers

- [Office Director](https://www.globalkeysolutions.net/people/sean-m-boyd/e9ac4789-b489-402d-8fb7-e20eed2af01f)

Company: https://www.globalkeysolutions.net/companies/integra-lifesciences-corporation/cd77e730-dc06-470e-ae7b-58c860df5c29

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7