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The company had not established internal systems that result in timely and effective evaluation of events that may be subject to MDR requirements. Read More
Unclean assembly areas, incomplete repair data sheets, no documentation of service manager training and water damage with insects throughout the facility are but a sampling of observations in a Form 483 the FDA levied on medical device manufacturer Allied Medical of St. Louis. Read More
The FDA’s recent Warning Letter to Augustine Temperature Management focused on a single — issue problems with medical device reporting (MDR) — citing the Bloomington, Minn.,-based company for multiple failures to adequately develop, maintain and implement written MDR procedures. Read More
China-based Bioptimal International removed the heparin coating from the tubing for its thermodilution catheter without seeking FDA clearance for the device, earning the company a Warning Letter following a Nov. 6, 2023, inspection of the company’s Singapore facility. Read More
Shouldering the cost of FY25 federal employee pay increases may cause the FDA’s Office of Regulatory Affairs (ORA) to reduce the number of inspections it can conduct, said the office’s Associate Commissioner for Regulatory Affairs Michael Rogers during an Alliance for a Stronger FDA webinar Wednesday. Read More
The letter states that Philips failed to ensure its supplier’s validation of the injection molding process for its CT patient interface monitor. Read More
Cardinal Health received an FDA Warning Letter because the company is marketing Monoject convenience kits that include 3 mL, 10 mL, and 20 mL piston syringes and control syringes made by Chinese manufacturer Jiangsu Shenli Medical Production. Read More
Inadequate responses to the findings of an October 2023 FDA inspection of Royal Philips’ Suzhou, China, facility has earned the company a Warning Letter citing the risks of malfunctioning of cable connection failure and software defects. Read More