FDA 483 - BioMarin Pharmaceutical Inc. - February 28, 2020

An FDA inspection of BioMarin Pharmaceutical Inc., conducted from February 24 to February 28, 2020, identified a critical issue regarding regulatory reporting. The inspection report, a Form 483, indicated that the company did not submit all annual periodic adverse drug experience reports within the required 60-day timeframe following the anniversary date of application approval. Specifically, three periodic adverse event reports were submitted late to the agency for products including Aldurazyme (BLA 125058), Brineura (BLA 761052), and another product under BLA 761079, with delays ranging from 30 to 44 days. This observation pertains to requirements under the Federal Food, Drug and Cosmetic Act concerning pharmacovigilance and drug safety reporting. BioMarin Pharmaceutical Inc. is expected to address these deficiencies by implementing corrective actions to ensure timely submission of all future adverse drug experience reports and maintain compliance with federal regulations.