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

Source: https://www.globalkeysolutions.net/records/483/brammer-bio-ma-llc/2161d805-e248-4655-a1a9-2a74e7d43e16

> 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 in Cambridge, MA, a viral vector manufacturer, received a Form 483 with three observations during an inspection from February 1-10, 2021. The observations highlight significant issues with contamination control in equipment and facilities, inadequate employee training, and poor control over production records, indicating potential risks to product quality and integrity.

## Related Documents

- [483 - 2023-08-30](https://www.globalkeysolutions.net/records/483/brammer-bio-ma-llc/a4bc38a8-d879-4616-bbf6-d1cae2475acb)

## 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/df01a45e-77d0-4179-bd95-978ebd2395a6

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