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Companies most likely to benefit from the Medical Device Single Audit Program will include those selling products in Canada, along with manufacturers of finished medical devices and high-risk devices, said MDSAP expert Brian Ludovico, in an FDAnews webinar. Read More
Repro-Med Systems in Chester, N.Y. failed to submit a report to the FDA on steps taken to reduce a health risk posed from a device, inspectors found during a late 2016 inspection. Read More
The FDA cited three device manufacturers for a range of violations including unreported product changes and failure to properly investigate complaints. Read More
The FDA warned device manufacturer Lonza over inadequate validation, CAPA procedures, and other violations at its Walkersville, Md., facility. Read More
Repro-Med Systems in Chester, N.Y. failed to submit a report to the FDA on steps taken to reduce a health risk posed from a device, inspectors found during a late 2016 inspection. Read More
The FDA cited four devicemakers for a variety of problems observed during inspections, including a lack of written quality procedures, shipping products prior to approval, inadequate documentation, and failure to report a software change. Read More
The FDA has cited four device firms for a range of compliance and quality issues, including serious problems arising with failed devices and the steps companies take when devices break, are returned or fail completely. Read More
The FDA, in late April, issued warning letters to three medical device firms citing serious CAPA and other violations at their facilities, including inadequate complaint response, quality testing, and verification of shipping and packaging methods to ensure product integrity and sterility. Read More
The FDA cited eight device firms for a range of compliance issues including inadequate complaint procedures, lack of written quality procedures, shipping products prior to approval, inadequate documentation, and unreported software changes. Read More