FDA GMP and Global ISO Inspections Successful for Biosynth
US FDA GMP Inspection passed
We are pleased to announce that Biosynth’s site in Staad, Switzerland, has successfully passed the recent GMP inspection by the US FDA on 16 January 2024.
The inspection, carried out by the FDA confirmed the site to be fully compliant with the principles and guidelines of good manufacturing practices (GMP) and no findings were issued.
Global ISO Certification expanded to six sites
Furthermore, our continued harmonisation of quality systems has led to a sixth Biosynth site being added to our Global ISO certification. Biosynth have been on significant journey of expansion over the last two years, and we have been working hard to integrate our leading quality management system across our global sites.
The new Global ISO certificate, once issued, will include all of the following sites:
- Biosynth AG ‒ Staad, Switzerland
- Biosynth sro ‒ Bratislava, Slovakia
- Biosynth Ltd ‒ Compton, UK
- Carbosynth China Ltd ‒ Suzhou, China
- Biosynth GmbH ‒ Vienna, Austria
- Biosynth International ‒ Gardner, Massachusetts
