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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
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
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