Global contract manufacturing organization (CMO) Symbiosis Pharmaceutical Services has successfully completed the latest inspection by the US Food and Drug Administration (FDA) of its facilities in Scotland.

Headquartered in Stirling, UK, and specializing in the sterile manufacture of pharmaceuticals and biopharmaceuticals for clinical trials and the supply of commercial markets, Symbiosis recorded zero GMP observations from the FDA during the inspection in January 2025.

The FDA inspection was conducted over a seven-day period and focused on the ongoing fill/finish of commercial supplies of an AAV (Adino-Associated Virus) viral vector biologics product for a long-standing US big pharma client. The inspection outcome validates Symbiosis’ quality management systems, ensures continued adherence to FDA regulations, and reinforces the capability of Symbiosis to deliver high-quality biopharmaceutical sterile manufacturing solutions globally.

Colin MacKay, CEO of Symbiosis, said: “Achieving this successful FDA inspection outcome is a reflection of our team’s expertise and on-going commitment to quality excellence. In a rapidly evolving biopharmaceutical landscape, regulatory rigor and GMP operational performance are enduring priorities for the company and a fundamental part of our business and cultural ethos. We are proud to provide our clients with unparalleled confidence in our quality capabilities and how that diligence translates into product excellence.”