For Immediate Release

Marin Biologic Laboratories Marks Second Consecutive Year of a Successful FDA Inspection 

NOVATO, CA – August 19, 2024

Marin Biologic Laboratories, a leading biological and biopharmaceutical drug development contract research organization (CRO), proudly announces the successful completion of a surprise U.S. Food and Drug Administration (FDA) inspection. From July 23 through July 24, 2024, the FDA conducted an unannounced inspection of our state-of-the-art testing facility located in Novato, California. 

An FDA Consumer Safety Officer from ORA/Pharmaceutical Quality Operations Division IV performed a detailed surveillance inspection of our facility and our Quality and Laboratory Management Systems. The absence of a Form FDA 483, Notice of Observation, confirms our continuous commitment to meet and exceed regulatory and compliance requirements. This marks the second consecutive year of flawless compliance with cGMP standards for commercial drugs. This year’s unannounced audit underscores Marin Biologic Laboratories’ unwavering dedication to maintaining the highest standards of quality and regulatory compliance. 

Dr. Tania Weiss, Founder, President, and Chief Executive Officer of Marin Biologic Laboratories, remarked, “The success of this surprise FDA inspection is a notable achievement and a testament to our team's relentless focus on the quality of our work, quality assurance and regulatory compliance. This milestone reaffirms our steadfast commitment to delivering creative solutions and upholding the highest standards for clients including the quality of our work, timeliness, communications in all our operations.”

The FDA inspection further encourages Marin Biologic Laboratories to expand its service offerings, enhancing its capacity to drive scientific innovation and contribute significantly to the pharmaceutical and biotech industries. Dr. Weiss added, “Our team's dedication and expertise have been instrumental in achieving this milestone. We are excited to continue providing an even broader range of services to our clients, furthering our contribution to the critical field of pharmaceutical and biotech research, development, and commercialization.”