medical device FDA 483s

The author performed data analysis of medical device FDA Form 483s issued in FY2013. Was Design Controls, CAPA, or complaint handling the number one 483?

The FDA recently updated its webpage for “Inspections, Compliance, Enforcement, and Criminal Investigations” (http://bit.ly/FDA483s). The update was the addition of FY2013’s inspection observations (i.e., 483s). Medical Device Academy performed data analysis of the inspection observations report for FY2013. The high frequency of FDA Form 483s referencing CAPA and complaint handling was not a surprise, but the results of the Pareto analysis (http://bit.ly/ParetoChart) might surprise you.

If you sort the raw data from the FDA, instead of categorizing the observations first, you see that 21 CFR 820.100(a) (i.e., the CAPA procedure requirement) is the most frequently referenced section. Complaint handling, 21 CFR 820.198(a), is the second most frequently referenced section. CAPA even gets the third spot on the table to the left, while the highest-ranking of an individual section for design controls [i.e., 21 CFR 820.30(i)] is eighth. The problem with this approach is that there 244 different sections to review, and it’s difficult to identify which process areas to focus on. Therefore, Medical Device Academy categorized the data by section first and then sorted the data.

The section of the CFR referenced categorized the data from FY2013. For example, there are 15 different sub-sections related to section 21 CFR 820.198. Therefore, all 15 were grouped under one category. The categorization of the data allowed us to reduce the number of observation references from 244 to 32. By doing this, it was clear that CAPA (11.75%) and complaint handling (10.65%) are more frequently referenced in FDA Form 483s than the next most frequent section—medical device reporting (6.24%). However, categorizing the data first shows that design controls (21 CFR 820.30) were referenced more frequently than any other category in FY2013.

You may also expect to see a large percentage of Form 483 observations issued against management responsibilities. However, section 820.20 (i.e., management responsibilities) ranks 13^th out of 32 categories (4.05% in the table below). We even considered that maybe FDA inspectors were issuing fewer 483s against section 820.20 in FY2013 than previous years. However, FY2012 also had slightly more than 4% of the FDA Form 483s issued against this category.

The frequency of 13.25% for design controls may surprise you. However, when all 15 of the different observation references for design controls are combined into one category, there is a total of 582 observations. For the sake of comparison, only 12.68% of the FDA 483 observations were related to design controls in FY2012. Therefore, inadequate implementation of design controls (http://bit.ly/Implementing820-30) remains the most frequently referenced observation.

If you are interested in downloading the Excel spreadsheet that we used to create the above chart and graph, please follow this link: http://bit.ly/Download-Pareto483s.

Preventive Actions

The Pareto analysis can also be used to focus your internal auditors or a mock-FDA inspection. For example, your next audit might start with a review of the CAPA process, since that is the second most frequent observation reference by FDA inspectors (http://bit.ly/CAPAMistakes). Next, you may want to audit complaint records and medical device reporting (http://bit.ly/outsourcing-complaints). These are the third and fourth most frequent observation references. Finally, after you have finished these three areas, you should select a product line that has not been recently inspected by the FDA and perform an audit of the Design History File (DHF): http://bit.ly/AuditDesign.  The auditor should verify that all the changes made to the Device Master Record (DMR) have been documented and validated in accordance with your Design Controls procedure.

In addition to performing a mock-FDA inspection, you should also invest in training of employees in each of the four most critical areas:

1. Design Controls
2. CAPA
3. Complaint Handling
4. MDRs

Signing a training record to indicate that you read and understood a procedure does not meet the requirements for training personnel. You need to develop a training curriculum for each subject area with practical examples—not just bullet points copied from the QSR. In addition to reading and sharing the blogs that are referenced for each of the above areas, you might also consider reviewing the following blog about training effectiveness: http://bit.ly/TrainingExams.

If you are interested in training courses, Medical Device Academy has a library of pre-recorded webinars available: http://bit.ly/QA-RA-Webinars. We also have exams that can be used to verify training effectiveness after each webinar. Please let us know if you are looking for something specific because we develop new customized training webinars every month.