# FDA 483 - T2 Biosystems, Inc. - September 24, 2021

Source: https://www.keypedia.com/records/483/t2-biosystems-inc/24ef1572-bf0b-46ef-9b2f-479b98b375ec

> FDA 483 for T2 Biosystems, Inc. on September 24, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: T2 Biosystems, Inc.
- Inspection Date: 2021-09-24
- Product Type: other
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of T2 Biosystems, Inc. in Lexington, MA, a medical device manufacturer, revealed two significant observations. The firm failed to document corrective and preventive action activities as per its internal procedures. Additionally, T2 Biosystems, Inc. did not establish a required quality agreement with its sterilization contract manufacturer.

## Related Officers

- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.keypedia.com/companies/t2-biosystems-inc/7ac9132d-e54b-408f-b292-002f2b7bc35f

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