FDA 483 - Bedfont Scientific, Ltd. - October 31, 2019

An FDA inspection of Bedfont Scientific, Ltd., a medical device manufacturer located in Maidstone, Kent, United Kingdom, was conducted from October 28 to October 31, 2019. The inspection resulted in the issuance of an FDA Form 483, detailing several significant observations regarding the company's quality management system. The primary issues identified were inadequacies in critical areas, reflecting non-compliance with the U.S. Quality System Regulation. Specifically, procedures for corrective and preventive actions (CAPA) were found to be insufficient, with inadequate analysis of quality data and instances where identified problems, such as defective Steribreath tubes, were not fully addressed before closing corrective action tickets. Design control procedures were also deficient, as evidenced by design validation being performed on an incorrect firmware version and a lack of verification for new product requirements for the ToxCO device. Furthermore, software changes were not properly documented. The inspection also noted that products not conforming to specifications were not adequately controlled, with one unit failing tests but erroneously reported as "Pass" and released for distribution. Equipment calibration procedures were found to be lacking specific accuracy and precision limits, and no action was taken when equipment failed calibration. Finally, the company's internal quality audit procedures were not adequately implemented. Bedfont Scientific, Ltd. is required to thoroughly investigate these observations and implement comprehensive corrective actions to address each deficiency and ensure adherence to regulatory requirements. A formal response detailing these actions must be submitted to the FDA.