FDA EIR - Emergent Manufacturing Operations Baltimore LLC. - April 20, 2020

An FDA inspection of Emergent Manufacturing Operations Baltimore LLC, conducted from April 9 to April 20, 2020, initially focused on a pre-approval assessment for Raxibacumab (BLA 1255349 S-025). The scope expanded to cover Current Good Manufacturing Practices (cGMP) due to observed deficiencies. The inspection was performed under Compliance Programs 7346.832 and 7356.002A, addressing regulations such as 21 CFR 211.68(b) and 21 CFR 211.160(a). The agency issued a 5-item Form FDA 483, highlighting significant concerns. Key violations included inadequate controls over computer and related systems, failing to ensure data integrity. This involved electronic analytical data not being protected from deletion or manipulation, and a lack of audit trail reviews and investigations into numerous data alterations. Additionally, analytical balances and computer operating systems allowed unauthorized date and time changes. The inspection also found that established test procedures and laboratory control mechanisms were not consistently followed or documented at the time of performance. Instances of inconsistent sample identification numbers, uninvestigated deviations from test methods, and manual data corrections days after analysis were noted. Deficiencies in documenting stability sample analyses were also identified, such as inadequate records for sample storage conditions and preparation materials. Further observations included the quality control unit's responsibilities not being fully documented or followed, insufficient employee training in operations and cGMP, and inadequate segregation of areas for rejected components. Management acknowledged the observations and committed to a written response within 15 business days to address these findings.