# FDA 483 - Brammer Bio MA, LLC - February 10, 2021

Source: https://www.globalkeysolutions.net/records/483/brammer-bio-ma-llc/7e2cff7f-ec19-4630-bef4-eea4e3155ad7

> FDA 483 for Brammer Bio MA, LLC on February 10, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brammer Bio MA, LLC
- Inspection Date: 2021-02-10
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Brammer Bio MA, LLC, a viral vector manufacturer in Somerville, MA, was cited for a significant quality control failure. The firm shipped rejected and un-dispositioned lentiviral vector material to a client without the knowledge or approval of its quality unit. This lapse involved multiple lots of material over several months, indicating a failure in ensuring proper disposition and authorization before product release.

## Related Documents

- [483 - 2023-12-19](https://www.globalkeysolutions.net/records/483/brammer-bio-ma-llc/88974eb2-785d-4ac0-8675-933290ed8f16)

## Related Officers

- [Compliance Officer at FDA](https://www.globalkeysolutions.net/people/lauren-m-lilly/41582ad0-67b1-4c60-99e2-c1e3c63811c2)
- [Scott T. Ballard](https://www.globalkeysolutions.net/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Principal Consultant- CMC Biologics, Former FDA regulator with expertise in CMC and GMP for Biologics](https://www.globalkeysolutions.net/people/steven-e-bowen/0e32c7e6-285b-4cf1-90e1-8a7a12a38b0c)

Company: https://www.globalkeysolutions.net/companies/brammer-bio-ma-llc/02d4b0a5-bcfb-4911-a33b-4f5653300c72

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7