# FDA 483 - Brammer Bio MA, LLC - December 19, 2023

Source: https://www.globalkeysolutions.net/records/483/brammer-bio-ma-llc/88974eb2-785d-4ac0-8675-933290ed8f16

> FDA 483 for Brammer Bio MA, LLC on December 19, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brammer Bio MA, LLC
- Inspection Date: 2023-12-19
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Brammer Bio MA, LLC in Somerville, MA, from December 13-19, 2023, identified one significant observation. The firm failed to follow its written production and process control procedures for HEPA filter certification. This lapse involved incorrect certification frequency for a Laminar Air Flow hood used in manufacturing, indicating a deviation from established quality control protocols.

## Related Documents

- [483 - 2021-02-10](https://www.globalkeysolutions.net/records/483/brammer-bio-ma-llc/7e2cff7f-ec19-4630-bef4-eea4e3155ad7)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)
- [Program Division Director](https://www.globalkeysolutions.net/people/karlton-t-watson/fdf2a30c-35e0-4c1b-a676-af1350f55733)

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