The Difference Between Quality And Compliance
In case you haven’t noticed, FDA is tired of being the “bad guy”. While they do not back-off of their responsibility to enforce the applicable Code of Federal Regulations for a millisecond, their budgets are strained, they are frequently understaffed and, human nature being what it is, are weary of playing the never-ending game of “Gotcha” with the companies they regulate.
FDA is also populated with some very sharp and talented people, and they know how to analyze data. For example, FDA is fully aware that the chart showing the categorized reasons for medical device 483s in 2005 is essentially the same today. That’s right, the same 483-worthy problems (CAPA, Design Control, Documentation, Production and Process Control, i.e., Process Validation, and Management Responsibility) that have existed in the device industry for years have not shown any appreciable improvement, despite the implementation of the Quality System Regulation circa 1997.