# FDA 483 - bluebird bio, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/bluebird-bio-inc/058e8097-4577-460e-a470-2dc9eafdab1f

> FDA 483 for bluebird bio, Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: bluebird bio, Inc.
- Product Type: biologics
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Bluebird bio, Inc. in Cambridge, MA, a contract test laboratory, revealed significant deficiencies in quality oversight, including poor sample handling, untimely testing and disposition of lentiviral vector batches, and inadequate documentation. The inspection also cited incomplete investigations, a failure to perform required preventative maintenance on temperature-controlled units, and a lack of verification for electronic data backup and recovery. These observations highlight systemic issues in the firm's quality control and data integrity practices.

## Related Documents

- [483 - 2025-03-20](https://www.keypedia.com/records/483/bluebird-bio-inc/a682a6c2-c2bf-4360-b7d7-02aa233deffa)

## Related Officers

- [Strategic Expert at NovoNordisk; Retired from FDA](https://www.keypedia.com/people/debra-m-emerson/58bd7fac-28eb-4369-b149-13a24cc00cf7)
- [Investigator](https://www.keypedia.com/people/alice-silva/b4b46db5-2b1a-452c-a403-9265a8785330)

Company: https://www.keypedia.com/companies/bluebird-bio-inc/8225820d-8c44-442b-8df6-583fe3dc7361

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