FDA EIR - Emergent Biosolutions LLC - December 21, 2017

An FDA Level I Good Manufacturing Practice (GMP) inspection of Emergent BioDefense Operations Lansing LLC, a vaccine manufacturer in Canton, MA, was conducted from December 12 to December 21, 2017. The inspection, following Compliance Program 7345.848 for biological drug products regulated by CBER, identified 12 observations detailed in an FDA Form 483. Key violations included incomplete or inaccurate Biological Product Deviation Reports (BPDRs), particularly concerning cracked vials and sterility test failures. The company failed to implement effective corrective actions for persistent low-level mold, yeast, and bacterial isolates found throughout the facility. Significant facility deficiencies were noted, such as gaps around utility piping, unsealed light fixtures, and peeling paint in manufacturing rooms. Investigations into quality issues were often incomplete, failing to identify root causes of contamination. Corrective and preventative actions were frequently delayed or inadequate, exemplified by late BPDR submissions due to employee training gaps and the continued use of an inadequate level sensor in a bioreactor. Furthermore, the company did not ensure updated ACAM2000 product package inserts, containing critical handling instructions, were provided to the CDC. Timeliness issues plagued quarterly and annual environmental monitoring and water trend reports. Equipment cleaning validation was deficient, with no established "dirty hold times." Qualification studies for temperature-controlled units lacked loaded temperature mapping. Process and Instrumentation Diagram (P&ID) drawings were not current, and preventative maintenance records lacked sufficient detail. Lastly, air pressure differential in pre-viral rooms was found deficient. Management committed to responding to the FDA within 15 business days, initiating immediate actions like BPDR correction and facility repairs.