The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently warned four medical device makers about a range of failures in procedures and processes. Two letters were sent to eye product manufacturers in the US, a third to a US developer of hemostatic products, and the fourth was related to a German company’s blood collection system.
New 510(k) needed for SAFE-T-FILL blood tubes
Kabe Labortechnik of North Rhine-Westphalia, Germany received a warning letter on May 9, following an inspection from 6-9 January.
The company manufactures SAFE-T-FILL capillary blood collection systems. According to the letter, the company violated quality system regulations, with processes not up to current good manufacturing practice (GMP) standards. For example, it did not validate the manufacturing process for the SAFE-T-FILL systems, which are filled onsite with an anticoagulant coated in a capillary rod, a “critical component” in the device, the agency noted.
Software used to inspect the coated capillary rods “was installed many years ago and has not been validated,” according to the letter.
Given that the machines and software are not validated, it’s unclear how the products meet quality specifications, FDA concluded. The agency asked the company to provide a systemic corrective action plan for all devices manufactured and sold in the US.
“Design changes, including the impact of cumulative changes should be assessed to determine if a new 510(k) is needed,” FDA advised.
FDA also flagged failure to develop, maintain and implement medical device reporting (MDR) procedures, such as a plan for reporting adverse events promptly to FDA.
The agency wrote that it is taking steps to refuse entry of these devices into the United States – detention without physical examination – until these violations are addressed and gave the company 15 working days to respond to the letter. RAPS.org