FDA 483 - Emergent Biodefense Operations Lansing LLC - October 04, 2019

Emergent BioSolutions, located at 3500 N. Martin Luther King Jr. Blvd., Lansing, MI, underwent an FDA inspection from September 30 to October 4, 2019. The inspection, documented under FEI number 1873886, identified key compliance issues within the manufacturing operations overseen by Senior Vice President Dino Muzzin.

The FDA's observations highlighted two primary concerns. First, there was inadequate segregation between inactivated and active Mycobacterium tuberculosis cultures in a specified area of Building (b)(4). This lack of proper separation poses potential cross-contamination risks, which could compromise product safety and integrity. Second, the facility lacked a written procedure clearly defining the use and control of packaged materials, identified as (b)(4). This absence of documentation could lead to inconsistencies in handling and quality control processes.

These observations are preliminary and do not constitute a final determination of compliance status. Emergent BioSolutions is encouraged to address these issues promptly. The company may discuss objections or corrective actions with the FDA representatives or submit further information to the FDA at the provided contact details.

To align with regulatory expectations, Emergent BioSolutions should implement corrective measures to ensure proper segregation of cultures and establish comprehensive written procedures for material use and control. These actions will help mitigate risks and enhance compliance with FDA standards.