BioMarin Pharmaceutical, Inc. – FDA 483, Jun 9, 2026

BioMarin Pharmaceutical, Inc. in Novato, CA, received a Form 483 citing significant deficiencies across its API Biotech Drug manufacturing operations. Observations include inadequate quality oversight with persistently failing analytical methods, poor facility maintenance, and insufficient equipment requalification. Additionally, the firm failed to implement proper corrective actions, exhibited deficient microbial control, and had inadequate lifetime validation for chromatography resins and manufacturing process controls.