# FDA 483 - TEI Biosciences, Inc. - November 02, 2018

Source: https://www.keypedia.com/records/483/tei-biosciences-inc/f2009480-3d6f-4f3e-aea8-f78bde242f03

> FDA 483 for TEI Biosciences, Inc. on November 02, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TEI Biosciences, Inc.
- Inspection Date: 2018-11-02
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: TEI Biosciences, Inc. in Boston, MA, was cited for significant deficiencies in contamination control, process validation, and quality system procedures during an FDA inspection. Observations included inadequate bacterial endotoxin testing for EBM medical devices like Xenform Soft Tissue Repair Matrix, insufficient environmental controls in ISO 7 clean rooms, and failures in corrective and preventive actions. The firm also lacked proper quality agreements and oversight for critical suppliers, indicating systemic quality control issues.

## Related Documents

- [WARNING_LETTER - Unknown Date](https://www.keypedia.com/records/warning_letter/tei-biosciences-inc/30fddd34-0b21-442c-9ca3-9866470a5562)
- [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)
- [483 - 2023-05-17](https://www.keypedia.com/records/483/tei-biosciences-inc/e7910cb5-6a76-435c-a8ac-24193d7d07b2)

## Related Officers

- [Diane M. Biron](https://www.keypedia.com/people/diane-m-biron/12eb885a-3ae3-449d-907e-36133dbdb194)
- [CSO at FDA](https://www.keypedia.com/people/justine-m-corson/5f6e4477-f060-47f1-9165-a63fd6a36226)

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