# FDA 483 - Integra LifeSciences Corporation - July 02, 2018

Source: https://www.keypedia.com/records/483/integra-lifesciences-corporation/38a41c9f-5f70-400a-a156-1ff227e3ccee

> FDA 483 for Integra LifeSciences Corporation on July 02, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Integra LifeSciences Corporation
- Inspection Date: 2018-07-02
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: Integra LifeSciences Corporation in Cincinnati, OH, was inspected and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for corrective and preventive actions, complaint handling, product identification and traceability, and design change controls. These issues indicate a systemic failure to maintain proper quality management for medical devices.

## Related Documents

- [WARNING_LETTER - 2023-05-17](https://www.keypedia.com/records/warning_letter/integra-lifesciences-corporation/b6055000-b7f5-4d2d-bef9-c5cebd9b5863)
- [WARNING_LETTER - 2024-08-22](https://www.keypedia.com/records/warning_letter/integra-lifesciences-corporation/ad10acef-4212-455a-b328-1da9842de1d6)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

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

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22