FDA 483 - BioMarin Pharmaceutical, Inc.

BioMarin Pharmaceuticals, Inc. in Novato, CA, a drug substance and drug product manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included incorrect procedures lacking specific instructions for consistent manufacturing operations, particularly concerning WFI use, cleaning, and storage. Additionally, the firm's process validation for storage conditions was found to be inadequate and lacked specific details.