Bedfont Scientific Ltd, based in Harrietsham Kent, has been in business of designing and manufacturing medical devices for 40 years. Revered as pioneers in the breath analysis world, their monitors offer a quick, efficient and non-invasive approach to help not only improve, but save lives, one breath at a time.
In response to the recent US Food and Drug Administration’s (FDA) decision to temporarily detain Bedfont products without physical examination Bedfont Scientific’s General Manager and long-term American Distributor have spoken.
Jason Aversano, spokesperson for CoVita, says, “I have personally been working with Bedfont Scientific since 1988 and know the high quality of their products is unanimous worldwide. CoVita has every confidence that Bedfont Scientific will resolve these minor regulatory observations that are an unfortunate side-effect with products that are always evolving to best meet consumer’s needs.”
Jason Smith, General Manager at Bedfont Scientific, comments, “We respect the FDA’s choice to provisionally interrupt Bedfont importing into the USA, it is their duty to ensure products are compliant. We have welcomed the opportunity to provide a corrective action report and in fact have corrected most of the observations since our FDA audit in September 2015, within the 15 day period provided in order to lift the momentary detainment. This is the first time in 40 years we have had to handle a matter such as this but respectfully, we are trying to remain in compliance with the increasingly complex regulatory world, whilst trying to always innovate out products to help improve the world’s health.”
