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

The FDA conducted a Pre-License Inspection of Brammer Bio MA, LLC's Somerville, MA warehouse facility from February 1 to February 10, 2021. This inspection, carried out under Compliance Program Guide 7345.848 for Biological Products, focused on the facility's quality, facilities and equipment, and materials systems. The primary finding, documented in a Form FDA 483, concerned the unauthorized shipment of rejected or non-dispositioned biological product material (filled vials of a critical component) to a client on multiple occasions between November 2020 and January 2021. These shipments proceeded without the required approval from the quality unit, a deficiency attributed to a procedural change that inadvertently removed critical quality oversight for certain "quarantine shipments." Additionally, during discussions with management, an issue was raised regarding the lack of periodic testing for critical container closure components, such as vials and stoppers, to confirm attributes like sterility, bioburden, or endotoxin, with the firm relying solely on supplier certificates. In response, Brammer Bio committed to submitting a detailed written reply to the FDA 483 within 15 working days and indicated plans to implement periodic testing for the identified critical materials.