FDA 483 - BioMarin International Limited - December 13, 2024

Biolnlarin International Limited, a drug product manufacturer in Ringaskiddy, Ireland, was cited for significant deficiencies during an FDA inspection. Observations included poor aseptic practices and inadequate environmental controls for sterile drug product manufacturing, a failure to thoroughly investigate and trend microbiological contamination, and inadequate laboratory controls for environmental monitoring. These issues indicate a high severity regarding potential product contamination and quality control failures.