Baxter Healthcare Corporation – FDA 483, Feb 9, 2024

Baxter Healthcare Corporation, a sterile drug manufacturer in Marion, NC, received a Form 483 with seven observations, including repeat findings. The inspection revealed significant deficiencies in production and process controls, particularly concerning particulate matter prevention and visual inspection programs. Additionally, issues were noted in laboratory controls, water for injection systems, complaint handling, and equipment maintenance, indicating a systemic lack of robust quality oversight.