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Home » warning letters

Articles Tagged with ''warning letters''

Edge Biologicals, Outset Medical snared by FDA warning letters

July 20, 2023
By Mark McCarty
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.
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Maker of orthodontic planning software snares FDA warning for software validation lapse

June 28, 2023
By Mark McCarty
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.
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After yearlong break, OPDP sends new letter

June 16, 2023
By Mari Serebrov
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.
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FDA warning letters hint that med-tech compliance programs drifted during COVID

June 7, 2023
By Mark McCarty
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.
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Sea-Long Medical says FDA inspection ‘a good learning experience’

June 2, 2023
By Mark McCarty
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.
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Toy bulldozer moving FDA letter blocks

Medtronic clears 2021 FDA warning letter for Northridge CGM manufacturing site

April 26, 2023
By Mark McCarty
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.
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FDA website and logo

FDA drops warning letters on Abbott’s Canadian operation and North American Diagnostics

April 19, 2023
By Mark McCarty
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.
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Maker of femoral resurfacing cup hit with warning for failure to file new 510(k)

April 5, 2023
By Mark McCarty
The U.S. FDA has issued a guidance on when to file a new 510(k) for a class II device that has undergone significant modification, but that doesn’t mean everyone in the device business is paying attention. The FDA hit Synovo Production Inc., of Fullerton, Calif., for a number of violations of the Quality System Regulation (QSR), but also alleged that the manufacturer/specification developer made a number of modifications to its femoral resurfacing cup for hip implants without a new regulatory filing, leading the agency to direct the company to immediately cease production of the device.
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Hand holding FDA blocks

FDA hits another Olympus endoscope manufacturing site with warning letter

March 20, 2023
By Mark McCarty
The U.S. FDA’s surveillance of duodenoscopes and other endoscopes was initially driven by concerns about device sterility, but recent inspections of manufacturing sites operated by Olympus Medical Systems Corp., in Japan have fed warning letters for lapses from various regulations. In the latest warning letter, the agency cited one of the company’s sites in Tokyo for both quality system and medical device reporting lapses, the second warning letter issued to the company in roughly three months.
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Toy bulldozer moving FDA letter blocks

OUS device makers on FDA’s short list for warning letters

Feb. 10, 2023
By Mark McCarty
It may still be true that a majority of medical devices are manufactured in the U.S., but that doesn’t stop the FDA from dropping a warning letter on facilities located outside the U.S. (OUS). In one of these warning letters, Microvention Inc., of Aliso Viejo, Calif., received a warning letter for its plant in Costa Rica, although the FDA waited until the second week of February to post the Sept. 30, 2022, warning.
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