# FDA 483 - bluebird bio, Inc. - March 20, 2025

Source: https://www.globalkeysolutions.net/records/483/bluebird-bio-inc/a682a6c2-c2bf-4360-b7d7-02aa233deffa

> FDA 483 for bluebird bio, Inc. on March 20, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: bluebird bio, Inc.
- Inspection Date: 2025-03-20
- Product Type: biologics
- Office Name: New England District Office
- Summary: An FDA inspection of 2seventy bio, Inc. in Cambridge, MA, identified a significant deficiency in their viral vector testing laboratory. The firm failed to maintain complete laboratory records, specifically regarding the adequate qualification of a DNA plasmid reference standard critical for testing the viral vector used in manufacturing drug product ABECMA. This issue highlights a lack of proper control over essential testing processes and data integrity.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/bluebird-bio-inc/058e8097-4577-460e-a470-2dc9eafdab1f)

## Related Officers

- [Scott T. Ballard](https://www.globalkeysolutions.net/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)

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

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144