Subcommittees of the House Committee on Energy and Commerce heard testimony last week from the Government Accountability Office’s Mary Denigan-Macauley and from Janet Woodcock, Director of FDA’s Center of Drug Evaluation and Research, about the state of FDA’s foreign drug establishment inspection program.
Between January 2016 and May 2019, you recorded approximately 397 customer complaints related to container closure issues (e.g., approximately 60%), product separation, lack of effect and adverse events. Your quality unit failed to adequately review these complaints, identify trends, and implement effective CAPAs. During the inspection you explained that these lapses in quality system performance were due to underperforming staff, who had since been dismissed. In your response, you attributed these and other quality related issues to under staffing of the quality unit as your business expanded.
Your response is inadequate because you failed to appropriately address your quality unit not performing their required duties. Your firm must provide the quality unit with the appropriate authority, sufficient resources, and staff to carry out its responsibilities to consistently ensure drug quality.
Continuing the trend of making me petrified about generics, this warning letter is a roller coaster read. One big set of failures to actually investigate and apply appropriate resources to the quality unit. And then the management had the gall to blame the employees.
80+ years of quality principles ignored. I personally thought the FDA was being overly nice.
There are basically three questions to answer:
Do you have a properly established, staffed, and managed Quality Unit?
Does your Quality Unit have appropriate responsibilities and authority?
Does your Quality Unit have access to the data it needs to make informed decisions?
The FDA has posted the 2019 483 observations as an excel file. The FDA has made these files available every year since 2006 and I find them to be one of my favorite tools for evaluating regulatory trends.
So for example, looking at change related 483 I see:
Theresa Mullin, FDA’s Associate Director for Strategic Initiatives for the Center for Drug Evaluation and Research recently gave a presentation “Update from FDA CDER” at GMP by the Sea (I need to go to that that some-year).