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 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.

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 · 2161d805-e248-4655-a1a9-2a74e7d43e16