The U.S. FDA posted two warning letters to device makers in the second week of March 2024, one each to Exactech Inc., of Gainesville, Fla., and the other to Nobles Medical Technology II Inc., of Fountain Valley, Calif. The themes of these warnings are entirely different, with Noble receiving a warning regarding clinical trial oversight and Exactech taking a hit for routine good manufacturing compliance issues, showing that the FDA is active in the post-COVID compliance realm.
The U.S. FDA’s warning letter to Fresenius Kabi AG of Homburg, Germany highlighted several problems with the compliance practices at the company’s plant in North Andover, Mass., but there is more than just a compliance issue at play. Fresenius had acquired the Ivenix infusion pump and the inspected research and development site in its 2022 acquisition of Ivenix Inc., another example of the regulatory and compliance hazards of acquisitions in the med-tech space.
The demand for semaglutide, a GLP-1 drug, and other popular prescription weight-loss drugs is adding to the U.S. FDA’s regulatory load as more and more companies are offering unapproved knockoffs of the products directly to consumers. The FDA posted two warning letters Feb. 13 – to Miami-based US Chem Labs and a New-York company, Synthetix Inc. doing business as Helix Chemical Supply – citing the companies for misbranding unapproved semaglutide and tirzepatide, also a GLP-1 drug, by marketing them on the Internet, along with claims about their therapeutic benefits.
U.S. FDA warning letters to device makers seemed to be on pause for a couple of years, but the agency is picking up the pace with two warnings posted July 18. Outset Medical Inc., of San Jose, Calif., was previously known to be the recipient of a warning letter, but Edge Biologicals Inc. of Memphis, Tenn., took in a warning letter that is replete with repeat violations disclosed in 2015 and 2018, as well as a warning letter issued 11 years ago.
Makers of dental equipment don’t typically show up on the U.S. FDA enforcement radar screen, but the introduction of biologics and software into routine dental practice has upped the regulatory stakes. This can be seen in the June 20, 2023, warning to Vitang Technology LLC, of Tustin, Calif., which cited the company for failure to validate a change of software used in orthodontic treatment planning systems, but the FDA reinforced the notion that claiming that the agency approved or cleared the device is also a violation of the Code of Federal Regulations.
In its first untitled letter in more than a year, the U.S. FDA’s Office of Prescription Drug Promotion (OPDP) took Xeris Biopharma Holdings Inc. to task for two webpages promoting the company’s Recorlev.
The U.S.FDA posted two warning letters to medical device manufacturers June 6, one each to Irhythm Technologies Inc., and Steiner Biotechnology LLC, and both warnings include citations for marketing for claims that are not in the FDA-reviewed product labels.
U.S. FDA inspections are not always a pleasant experience, particularly when the end result is a warning letter. One company, Sea-Long Medical Systems LLC of Waxahachie, Texas, says the experience was a positive experience in that the company’s new ownership gained an important appreciation for the necessary rigors of medical device manufacturing.
Dublin-based Medtronic plc, and the U.S. FDA have wrapped up their discussion of the December 2021 warning letter for the company’s manufacture of continuous glucose monitors, clearing a hurdle that was critical in restoring the company’s footprint in the U.S. market. Left unanswered from the resolution of the warning letter is whether the FDA believes that device makers need to track the number of devices in distribution vs. those in actual use in order to properly calculate the risk of device failure based on postmarket surveillance.
There are worse things for U.S. FDA-regulated companies than a warning letter from the agency, but both Abbott Point of Care Canada Ltd., and North American Diagnostics LLC were hit with a warning letter that included citations for failure to comply with the Quality System Regulation (QSR). North American may have believed it was no longer required to comply with the QSR as it ceased the manufacture of its COVID-19 rapid antigen test kits in July 2021, but the FDA advised the company that compliance is required so long as there is some chance that an adverse event arises in connection with the company’s product.