483
BioMarin Pharmaceutical, Inc.FDA 483 - BioMarin Pharmaceutical, Inc. - April 02, 2021
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Record Details
An FDA inspection of BioMarin Pharmaceutical, Inc. in Novato, CA, a drug substance manufacturer, revealed two significant observations. The firm lacked written procedures for requesting and shipping samples to control laboratories and for receiving, reviewing, and filing test results from contract laboratories. These deficiencies indicate inadequate control over critical quality processes involving external laboratories.
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ID · 68119bf5-5042-4336-9c03-7fde3f113010