FDA EIR - Emergent Biodefense Operations Lansing LLC - September 27, 2018

An FDA inspection of Emergent BioDefense Operations Lansing LLC, a manufacturer of licensed anthrax vaccine adsorbed (BioThrax®), was conducted from September 20-27, 2018. The inspection, performed as a Level 1 team review under the FY18 Team Biologics work plan and Compliance Program 7345.848, verified that previous objectionable conditions from a 2016 inspection had been corrected. However, the current inspection resulted in a FORM FDA 483, identifying significant deficiencies within the firm’s Quality Control Unit. Key issues included inadequate written procedures and adherence to responsibilities, particularly concerning the management of third-party contract fillers. Specifically, the Quality Unit exhibited a lack of routine compliance audits for a sister facility, insufficient follow-up on findings from other filler audits, and incomplete documented analysis of regulatory observations or major deviations from these contractors. Furthermore, change control processes for fillers lacked comprehensive impact assessments and validation requirements. Additional violations highlighted the absence of Quality Unit review for certain work orders, potentially allowing quality problems to go unaddressed. The firm also failed to establish adequate quarantine or containment protocols for questionable raw material batches found to contain organisms. Effectiveness checks within change control procedures were not clearly defined, leading to inconsistent application, and some deviation impact assessments were incomplete, specifically regarding particle size analysis. Management committed to providing a written response to the FDA to address these objectionable conditions.