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It can help to learn more about an FDA inspection team ahead of time, said inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar.
The FDA handed cardiac device manufacturer Atrium Medical a Form 483 after a July-August 2022 inspection of its facility in Merrimack, N.H., found inadequate design and process controls among other lapses described as repeated systemic deficiencies.
Abbott has issued an advisory to customers warning of potential early structural valve deterioration (SVD) of its Trifecta Valve and Trifecta Valve with Glide Technology (GT) bovine heart valves, occurring five years or less after being implanted.
Medtronic is relaunching its Harmony Transcatheter Pulmonary Valve (TPV) system after a March 2022 recall following six reports of a failure of the capsule at the end of the delivery catheter.