FDA 483 - BioMarin Pharmaceutical, Inc. - April 02, 2021

BioMarin Pharmaceutical, Inc., located at 46 Galli Drive, Novato, CA, underwent an FDA inspection from March 25 to April 2, 2021. The inspection, conducted under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, identified several key compliance issues at this drug substance manufacturing facility.

The primary observations included the absence of a written procedure for requesting and shipping samples to control laboratories for testing. Specifically, the Sample Information Sheet provided to a contract laboratory contained incorrect specification document numbers and reconstitution volumes for stability sample testing of BMN111 lots. Additionally, there was no verification process for request information before dispatching test forms and samples.

Another significant issue was the lack of a formal procedure for receiving, reviewing, and filing test results from contract laboratories. Results were distributed via email without adequate control over the documents obtained, posing a risk to data integrity and quality assurance.

The FDA requires BioMarin to address these deficiencies by establishing and implementing written procedures for both sample management and test result handling. These actions are crucial to ensure compliance with FDA regulations and to maintain the integrity and reliability of drug substance testing processes. BioMarin is encouraged to discuss corrective actions with FDA representatives or submit their plans to the FDA for review.