AssurX Blog
Straight talk for regulated industries.
FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014
FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for the Fiscal Year 2014 - In our last FDA FastStats series of the year, we look back at all FDA 483 Inspectional Ob [...]
FDA Update on UDI Implementation for Registered Medical Device Establishments
In case you missed it, the FDA issued this update on UDI yesterday: Having passed the first Unique Device Identification System compliance date of September 24, 2014 (for Class III dev [...]
Got Safe Beef? New Report Suggests the US Doesn’t
FSMA: Got Safe Beef? New Report Suggests the US Doesn't: The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Bas [...]
FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies
FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies: In our latest infographic analysis, today's post highlights medical device warning l [...]
FDA FastStats: A Look Back at 2013 Medical Device 483 Observations
FDA FastStats: A Look Back at 2013 Medical Device 483 Observations: As we approach the end of 2014, we will take a look back at FDA's stats on various topics sourced from their Case fo [...]
FDA’s Local Offices Flex Regulatory Muscle
In our latest round-up, it was the District Offices turn to chime in on medical device company alleged shortcomings. As expected, the FDA is shifting more and more of its regulatory fo [...]
