# FDA 483 - TEI Biosciences, Inc. - May 17, 2023

Source: https://www.keypedia.com/records/483/tei-biosciences-inc/e7910cb5-6a76-435c-a8ac-24193d7d07b2

> FDA 483 for TEI Biosciences, Inc. on May 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TEI Biosciences, Inc.
- Inspection Date: 2023-05-17
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: TEI Biosciences, Inc. received a Form 483 citing significant deficiencies in quality system controls for their implantable medical devices. Observations included failures in controlling nonconforming product, establishing corrective and preventive actions, validating critical test methods (like bacterial endotoxin and bioburden), preventing contamination, validating production software, and managing storage areas. These issues collectively indicate a lack of robust quality oversight impacting product sterility and safety.

## Related Documents

- [WARNING_LETTER - Unknown Date](https://www.keypedia.com/records/warning_letter/tei-biosciences-inc/30fddd34-0b21-442c-9ca3-9866470a5562)
- [483 - 2018-11-02](https://www.keypedia.com/records/483/tei-biosciences-inc/f2009480-3d6f-4f3e-aea8-f78bde242f03)
- [WARNING_LETTER - 2018-11-02](https://www.keypedia.com/records/warning_letter/tei-biosciences-inc/6dc82e38-4b99-4c1f-8528-35479924c201)
- [483 - 2021-11-12](https://www.keypedia.com/records/483/tei-biosciences-inc/6fbe531a-6aa5-43a6-a858-e69e76e1f5c0)

## Related Officers

- [Diane M. Biron](https://www.keypedia.com/people/diane-m-biron/12eb885a-3ae3-449d-907e-36133dbdb194)
- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.keypedia.com/companies/tei-biosciences-inc/c278d7b4-2ffa-44fa-86c3-e15b039953a3

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94