# FDA 483 - Integra LifeSciences Corporation - June 05, 2024

Source: https://www.keypedia.com/records/483/integra-lifesciences-corporation/2670566c-7503-492c-8109-4527bc0e0d4a

> FDA 483 for Integra LifeSciences Corporation on June 05, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Integra LifeSciences Corporation
- Inspection Date: 2024-06-05
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of Integra LifeSciences Corporation revealed significant deficiencies in quality control and manufacturing processes. The firm released medical devices despite out-of-specification endotoxin results and failed to adequately investigate environmental contamination in its cleanroom. Additionally, issues were noted in process validation, CAPA management, storage area controls, and finished device acceptance procedures, indicating a systemic lack of adherence to quality system regulations.

## Related Officers

- [Diane M. Biron](https://www.keypedia.com/people/diane-m-biron/12eb885a-3ae3-449d-907e-36133dbdb194)
- [Eric C. Schmitt](https://www.keypedia.com/people/eric-c-schmitt/f2716c8c-f06e-4519-a1e7-63a3ef6e07fb)

Company: https://www.keypedia.com/companies/integra-lifesciences-corporation/c373538e-8477-4e28-a80f-0da00bfe55ba

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144