If a company is selling medical devices in the United States, it knows it will eventually undergo an FDA inspection in its future, even if it has had one in the past. Like most people, the company probably has limited time available to get everything done and prepare for an inspection. So how does a company approach getting ready for that inevitable inspection?
As people become more experienced, they learn that history repeats itself in many ways, and hopefully they can learn from the trials and tribulations of others’ experiences. FDA inspections are no different. The focus or hot items that FDA focuses on during an inspection can change. Therefore, a medical device company’s last inspection may not be indicative of its next inspection. By looking at recent FDA inspection data, a company can obtain a better understanding of what FDA investigators are looking for and finding. Many of these findings end up in warning letters as well, so this data can give a head start toward preventing the dreaded warning letter.
FDA has published summary data of its FDA-483 findings, which resulted from inspections made during FDA fiscal year 2010. This is not just a bunch of FDA-483 forms published for some companies that were inspected. Rather, this data ranks the number of times certain observations were made during all FDA inspections in 2010 (817 total inspections) using the Turbo EIR automated software program, which is typically used by investigators during inspections. The data does not include information from FDA-483 forms that were manually written. This data can be accessed at http://www.fda.gov/ICECI/EnforcementActions/ucm255532.htm under “Devices.”
For example, the top FDA-483 citation made during medical device manufacturer inspections in 2010 was in violation of 21 CFR 803.17: “Written MDR procedures have not been developed, maintained, or implemented.” This top citation is closely followed by the number two citation which was violating 21 CFR 820.100(a): “Procedures for corrective and preventative action have not been adequately established.” It is noted that some of the observations are similar and could have possibly been combined. For example, if all design validation related citations had been totaled, its comparative ranking would have gone up the list.
Medical device companies should use this data to help prioritize their internal audit efforts. Understanding the temperature and the ebb and flow of FDA inspections can be very helpful. This data is one piece of the puzzle in helping companies to prioritize limited time and resources.
Brent Noblitt is a senior partner and cofounder of Noblitt & Rueland, a 23-year old professional firm providing quality, regulatory, and technical training/consulting services to medical device manufacturers around the world. Services include FDA and ISO compliance activities, quality system issues, auditing, and submissions. He has an MS in bioelectrical engineering from Purdue University and an MBA from Pepperdine University.