Biofortuna have successfully completed an FDA site inspection to retain their FDA registered manufacturing site status.
The inspection was carried out over several days in which the FDA thoroughly reviewed Biofortuna’s manufacturing, quality control and quality assurance procedures.
Biofortuna manufactures 510k approved IVD kits for sale in the US for their molecular diagnostics division. An increasing number of contract service clients are also planning to submit products for 510k approval, to be manufactured by Biofortuna’s contract manufacturing division.
Dr. Simon Douglas, Biofortuna CEO, commented: “The success of the recent FDA inspection is a testament to the quality of our processes and services we offer. I am delighted with the outcomes and look forward to increasing our sales into the US and helping our contract service clients gain 510k approval”
The company’s ISO 13485 accredited and FDA registered services include contract research and development, lyophilisation, air-drying, manufacturing, dispensing and kitting of diagnostic products.
About Biofortuna Ltd
Biofortuna Ltd is a leading diagnostics company offering both custom IVD manufacturing services and molecular diagnostic products. Biofortuna provides a complete solution for diagnostic companies looking to outsource elements of development and manufacture.
In addition, Biofortuna’s proprietary lyophilisation expertise produces ambient temperature, single step setup diagnostic kits.
Biofortuna currently offers molecular diagnostic products for HLA-disease identification, HLA pharmacogenetics and are currently developing a range of real-time blood group genotyping kits.
Biofortuna Media Contacts
Dr Simon Douglas
Chief Executive Officer