Brammer Bio MA, LLCDecember 19, 2023

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

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Record Details

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.

Company: Brammer Bio MA, LLC
Inspection Date: December 19, 2023
Product Type: Biologics
Office: Division of Northeast Imports
People: Priscilla M. Pastrana (investigator)
Karlton T. Watson (Program Division Director)

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ID · 88974eb2-785d-4ac0-8675-933290ed8f16