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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
Vitang Technology, a Tustin, Calif.-based manufacturer of 3D printed dental alignment devices, failed to seek the FDA’s clearance when it changed the software used with its UniSmile Clear Aligner, the agency said in a June 12 warning letter to the company. Read More
Companies might receive a documentation observation even though the CAPA procedures and defined process are fully compliant because of deficient documentation. Read More
Failure to establish corrective and preventive action (CAPA) plans tops the list of devicemakers’ FDA inspection observations year after year, but the situation is more nuanced than you might expect, according to one regulatory expert. Read More
iRhythm Technologies’ mislabeling of a cardiac monitor and its component software as well as failure to report serious adverse events, including two deaths, netted the devicemaker an FDA warning in late May. Read More
Failure to resolve at least six of 10 observations from an earlier inspection resulted in another Form 483 in January for Theweb2u.com, maker of the Therapik insect bite and itch relief device. Read More
A Form 483 cites Cocoa Beach, Fla.-based Ward Photonics for continuing problems with investigation and evaluation of customer complaints for possible medical device report (MDR) requirements. Read More