Edwall Elevator – FDA 483, Mar 10, 2023

Emergent BioSolutions Inc. received an FDA Form 483 following an inspection concluding on or before June 13, 2023. The inspection identified six significant observations related to non-compliance with Current Good Manufacturing Practice (CGMP) regulations, specifically 21 CFR Part 211. Key issues included the firm's repeated failure to adequately investigate foreign particle findings in drug substance batches, with investigations not extending to other potentially affected products and lacking identified root causes and follow-up. The FDA also noted the firm's insufficient review of discrepancies, inadequate process validation, and inappropriate test methods for Narcan Nasal Spray, with these being repeat observations from previous inspections. Furthermore, Emergent BioSolutions Inc. was cited for not having established written procedures for equipment cleaning, failing to conduct cleaning validation studies, and lacking an ongoing program for monitoring process control and product quality reviews for Narcan manufacturing. The firm also failed to establish and document the accuracy and suitability of its analytical test methods for Narcan components. Emergent BioSolutions Inc. is required to address these critical observations by submitting a comprehensive plan of corrective and preventative actions to the FDA.