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A critical component of any strong quality management system (QMS) for manufacturing FDA-regulated medical products is the presence of a structured approach to investigating root causes of product and process shortcomings, and then taking action to address the root cause(s) through the corrective and preventive action (CAPA) process. Read More
The former CEO of Utah-based device maker Dolor Technologies will be sentenced Nov. 8 on misdemeanor charges related to failure to seek FDA approval for a device to treat migraine headaches. Read More
Our coverage spans a bone graft product that caused a tuberculosis infection, a subcutaneous cancer treatment, a warning letter for an eye drop manufacturer, 300 higher risk patients with a recalled Medtronic cardiac pump, and a lawsuit by Insulet against a competitor for intellectual property theft. Read More
Despite customers’ reporting symptoms that included stroke, memory loss, atrial fibrillation, bradycardia and seizures after using Fisher Wallace Labs’ at-home cranial electrotherapy stimulator (CES) device, the company did not submit the required Medical Device Reporting within 30 days to let the FDA know that serious adverse events (SAE) had occurred. Read More
Stryker received an FDA Form 483 after a Jan. 17-24 inspection of its Portage, Mich., plant showed that the company did not have a formal unit to receive, review and evaluate complaints about its C2 Nerve Monitor device. Read More
Outset Medical has announced that it received a warning letter from the FDA for promoting use of its Tablo hemodialysis system for continuous renal replacement therapy (CRRT) which is outside of current indications for the device, and for a lack of clearance of TabloCart, an accessory for the system. Read More
Abbott’s corrective and preventive action (CAPA) activities and results have not been adequately documented, FDA investigators found during an inspection at the company’s Arecibo, Puerto Rico, location. Read More
Failure to review and submit medical device reports (MDR) within 30 days of receipt is the key observation in an FDA form 483 received by Philips North America following an Oct. 11-27, 2022, inspection of its Bothell, Wash., facility. Read More
A lack of procedures for receiving, reviewing and evaluating complaints by a formally designated unit is one of nine observations that an FDA investigator made during a Dec. 5-9, 2022, inspection of San Diego-based Integrated Orbital Implants. Read More