B-K Medical A/S – FDA EIR, Jan 26, 2017

A routine FDA inspection of BK Medical APS, a Danish manufacturer and specification developer of Class II diagnostic ultrasounds and biopsy instruments, was conducted from January 23-26, 2017. The inspection, carried out under the regulatory framework for medical device manufacturers, identified five significant issues detailed in an FDA Form 483.

The main violations included a failure to maintain comprehensive complaint files, with over 4,000 defective product returns not resulting in formal complaints. Service reports were deficient, as events were not consistently evaluated for Medical Device Reporting (MDR) requirements. Furthermore, the company's written MDR procedure lacked proper documentation and recordkeeping for assessing reportable events. The inspection also found that necessary investigations into complaints involving potential device or labeling failures were not conducted. Lastly, there was an absence of documented personnel training, specifically for employees responsible for complaint handling, indicating inadequate assurance of staff qualifications.

Mr. Bo Hansen, Managing Director of BK Medical APS, acknowledged all observations and committed to correcting the deficiencies, promising a written response to the FDA within 15 working days to outline corrective actions.