# FDA 483 - TEI Biosciences, Inc. - November 12, 2021

Source: https://www.keypedia.com/records/483/tei-biosciences-inc/6fbe531a-6aa5-43a6-a858-e69e76e1f5c0

> FDA 483 for TEI Biosciences, Inc. on November 12, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TEI Biosciences, Inc.
- Inspection Date: 2021-11-12
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: TEI Biosciences, Inc. in Boston, MA, was inspected and cited for significant deficiencies in quality system procedures. Observations included inadequate process parameter monitoring, unvalidated manufacturing processes, insufficient environmental control, and incorrect product labeling with extended expiration dates. Additionally, the firm failed to submit multiple Medical Device Reports for serious injuries and malfunctions within the required 30-day period.

## 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 - 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)
- [Investigator](https://www.keypedia.com/people/stephen-c-smith/426649fa-0e5b-4b35-ba41-636512a06a48)

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