FDA 483 - Marin Biologic Laboratories, Inc - April 28, 2023

Marin Biologic Laboratories, Inc. in Novato, CA, a contract testing laboratory, was cited with two observations during an FDA inspection. The firm failed to thoroughly investigate a batch failure, specifically lacking a root cause analysis for failed testing results. Additionally, their written procedures for cleaning and maintenance did not include essential preventative maintenance schedules for equipment.