Symbiosis Reports Successful Completion of FDA Inspection of Scotland Facilities

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Symbiosis Pharmaceutical Services, a global contract manufacturing organization (CMO) headquartered in Stirling, United Kingdom, has completed a successful inspection of its facilities in Scotland by FDA, Symbiosis said in a press release on March 3, 2025 (1).

The January 2025 inspection, which was conducted over a period of seven days, passed with zero good manufacturing practice (GMP) observations from FDA, Symbiosis said.

“Achieving this successful FDA inspection outcome is a reflection of our team’s expertise and ongoing commitment to quality excellence,” Colin MacKay, CEO of Symbiosis, said in the company’s press release (1). “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.”

According to Symbiosis, the inspection focused on ongoing fill/finish of commercial supplies of an adeno-associated virus (AAV) viral-vector-based biologic product for a major pharmaceutical client in the United States. The pharmaceutical client was not disclosed, nor the product; Symbiosis stated in its release that the client was “long-standing” (1).

“Symbiosis continues to thrive as a specialist fill/finish global CMO leader, fueled by a sustained increase in demand for its services which align with broader industry trends such as the number of biologics and injectable drugs in development and an increasing appetite for outsourced sterile GMP fill/finish services,” MacKay added in the release. “Maintaining our prevailing high standards of both customer service and quality compliance is part of our long-standing strategy to drive the continued organic growth of our core sterile manufacturing service offering principally to the US and European markets.”

Symbiosis previously reported the successful completion of a scheduled audit inspection by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK in 2020, followed by another successful, on-site inspection by MHRA of the company’s expanded facility in Stirling, UK, in 2021 (2,3).

In August 2024, FDA announced its Fiscal Year 2025 Center for Drug Evaluation and Research Office of Pharmaceutical Quality Experiential Learning Site Visit Program, which does not replace or supplement a regulatory inspection, but does allow FDA staff to observe commercial manufacturing and testing operations as well as pilot plants, with the goal of better understanding standard operations of the pharmaceutical industry and how those impact the developmental programs and commercial life cycles of drugs (4). The selection process gives priority to facilities on the basis of FDA staff training and a facility’s current compliance standing with FDA, among other considerations. Such visits are being made through the close of the fiscal year on Sept. 30, 2025.

As a result of a series of inspections in June and July 2024, FDA in January 2025 issued a warning letter to Sanofi summarizing “significant deviations” from current good manufacturing practice (CGMP) for APIs at the Framingham, Mass., facility of Genzyme Corporation, a subsidiary of Sanofi (5).

References

1. Symbiosis Pharmaceutical Services. Symbiosis Successfully Completes Gene Therapy Focused FDA Regulatory Inspection. Press Release. Feb. 3, 2025.
2. Symbiosis Pharmaceutical Services. Successful MHRA Regulatory Inspection for Symbiosis. Press Release. Sept. 29, 2020.
3. Symbiosis Pharmaceutical Services. Symbiosis Announces Successful MHRA Audit and Expanded Facility at its Stirling, UK Site. Sept. 15, 2021.
4. FDA. FDA Invites Drug Companies to Participate in Site Visitation Program. Press Release. Aug. 7, 2024.
5. FDA, Warning Letter 320-25-22, Sanofi, amended (CDER, January 2025).