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

Maquet Cardiovascular received a Form 483 with 17 observations, including several repeat observations related to complaint reporting, process validation, CAPAs and other issues. Read More

Baxter Healthcare landed an FDA warning letter that includes multiple repeat observations and issues related to test methods, CAPAs and over-infusion with its elastomeric infusion systems. Read More

In deciding to reorganize the Office of Compliance, CDRH made the pragmatic decision to focus its limited resources on encouraging quality rather than on compliance enforcements, OC Director Steve Silverman says. Read More

The FDA will create a device-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More

St. Jude has been handed a two-observation Form 483 related to its investigation procedure and supplier controls. 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

Advanced Magnetic Research Institute received an FDA warning letter related to violations in three clinical studies of a magnetic molecular energizer, including failure to get IRB approval. 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

The FDA and India’s Ministry of Health & Family Welfare have agreed to share information from quality inspections of devicemakers. 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