Brammer Bio MA, LLCFebruary 10, 2021

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

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Record Details

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.

Company: Brammer Bio MA, LLC
Inspection Date: February 10, 2021
Product Type: Biologics
Office: Division of Northeast Imports
People: Lauren M. Lilly (Compliance Officer at FDA)
Scott T. Ballard
Steven E. Bowen (Principal Consultant- CMC Biologics, Former FDA regulator with expertise in CMC and GMP for Biologics)

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ID · 7e2cff7f-ec19-4630-bef4-eea4e3155ad7