Bedfont Scientific, based in Harrietsham Kent, successfully passes another FDA inspection.
Bedfont Scientific, a local medical device manufacturer specialising in breath analysis, is pleased to announce that the US Food and Drug Administration (FDA) has completed a successful inspection at its premises. The audit found Bedfont to be compliant with Good Manufacturing Practice (GMP), which means their products are manufactured to the highest quality which is essential when you’re providing technology that saves people’s lives.
Louise Bateman, QA & RA Manager at Bedfont Scientific, says, “We are really pleased the FDA follow up audit went well and all previous observations were closed out. With this outcome, it shows we are working as a compliant company to FDA standards and are able to continue to provide high quality products to the USA. We look forward to working with the FDA in the future and to continue building on our relationship with them.”
Managing Director, Jason Smith, adds, “Bedfont’s aim for the future with this clean bill of health is to continue with their scientific contributions to health, including research and development into their H-pylori breath monitor. The monitor will be able to detect a harmful type of bacteria that can lead to cancer if left undetected. This type of bacteria affects around 50% of the world’s population and can be contracted through something as simple food and water, and with a H-pylori breath monitor we would be able to save those lives.”
