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Recently some of my clients received 483 observations for supplier controls and MDR reporting, but one of my clients asked which areas are FDA inspectors emphasizing. I noticed no significant changes, but I thought it was worth revisiting my Pareto Analysis of FDA 483s:
I downloaded the FY 2015 data from the FDA website and I performed the exact same analysis I performed in February 2014. There was a slight increase in the number of 483 observations issued from FY 2013 to FY 2015, however, the difference was only a 1% increase from 6.2% to 7.2% of the total number of 483s issued. There was an even smaller increase in the number of findings related to purchasing controls (i.e., 5.6% increased to 6.1%).
I noticed a slight drop in the number of findings related to design controls, CAPA and complaint handling. However, the overall trend for FY 2013 and FY 2015 is essentially the same. I’ll be publishing a blog this week about it and make the data analysis available as a download from my website.
So what’s the big deal?
This proves that the FDA inspectors continue to be predictable. The “playbook” for FDA inspections is the QSIT Manual. It hasn’t changed since 1996. Yet, companies continue to be shocked and amazed by FDA inspectors. If you want are interested in learning how to prepare for FDA inspections, I recorded a webinar you can download (FREE):
I recorded the webinar in May of 2014, but it’s been a couple of years and I’ve learned a few new tricks. Therefore, I’m going to re-record the webinar and update it for lessons learned. I’ll even share a few tools and approaches to avoid findings and reduce the risk of warning letters. I’m even evaluating a new application that is designed for teams to have private chats and file sharing during an inspection. Stay tuned to my webinars page and I’ll post that webinar soon. Maybe I’ll record something from Germany next month.
Until then, I am working on an webinar specific to medical device reporting. Many companies have still not updated their MDR procedures to reflect the eMDR process using electronic submissions gateways. Therefore, I’m releasing an updated procedure for MDRs and I am offering webinar bundle to train people how to comply with 21 CFR 803 and the procedure. The webinar is scheduled for June 9. I’m even offering two times to accommodate companies in Europe as well as the USA.
Here’s a link for the webinars page: http://medicaldeviceacademy.com/webinars/.
Based upon this latest Pareto Analysis, I think it’s time to update my supplier controls webinar too. Which would you prefer to watch first?
Supplier controls or FDA inspections?
Let me know by filling in my “suggestion box” form. The link is on my webinars page. I also appreciate suggestions and questions for weekly announcements.
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Rajani Kumar Sindavalam, PMP® Thanks Rob!
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