DexCom, a San Diego maker of continuous glucose monitors, has been warned over medical device reporting failures and problems with its MDR procedure. Read More

If devicemakers audit their procedures for equipment verification and validation, change control, documenting complaints, including complaints received orally, and CAPA recordkeeping, they will have touched on those parts of the quality system that most often generate findings during an FDA inspection. Read More

The FDA has warned Ultradent, a dental device manufacturer, for significant and repeated quality violations related to CAPAs, packaging, labeling and device design. Read More

NeoMedix wound up in the crosshairs of FDA investigators for online claims that its Trabectome tissue removal device is effective in treating glaucoma. Read More

Devicemakers preparing for an FDA inspection should take steps to avoid some of the most common mistakes, such as lapses in complaint-handling procedures, David Lim, president and CEO of www.RegulatoryDoctor.com, said during a recent FDAnews webinar. Read More

Just as Hospira’s Rocky Mount, N.C., production plant was starting to reel itself back from a devastating 2010 FDA inspection, the facility has been handed a fresh warning letter complaining that its corrective and preventive action procedures fall short of expectations. Read More

Citing the growing complexity of medical devices, the U.S. Food and Drug Administration says it will create a devices-only enforcement unit with subspecialists, where necessary, “to carry out effective oversight” of manufacturers. Read More

The reorganization of CDRH’s Office of Compliance and creation of a Division of Manufacturing Quality has provided a shot in the arm to the center’s Case for Quality Initiative — fueling two pilot programs designed to increase inspection efficiencies without sacrificing quality, OC Director Steve Silverman says. Read More

Amgen could not certify to an FDA inspector that it had evaluated a contractor that serviced its equipment, according to a recent warning letter. Read More

The FDA has posted the second warning letter in two weeks for Baxter Healthcare, this one citing supplier control slips and other issues at its Irvine, Calif., manufacturing plant. Read More

Documentation shortfalls led to a two-observation Form 483 for Eli Lilly following a Dec. 2 to Dec. 6 inspection. Read More