Had you asked me this question a year or so ago, I would have answered “You bet!” Actually, my answer is still “You bet!” but with a twist. A year ago, I would have offered that FDA inspections are much more stressful and involved. Today, I’m not so sure. Based on recent experiences, I might even suggest that a Notified Body inspection is more stressful than FDA. Of course this assumes that you don’t have product issues and FDA is not conducting a for-cause inspection. Also, keep in mind that FDA inspectors are law enforcement. Yes, they carry a badge.

So why would I suggest that a Notified Body inspection is more stressful? Last summer, a client was subject to a FDA inspection. I was brought in just a day or two before the FDA inspector was scheduled. When the FDA inspector arrived, the inspection went fairly smoothly. There were some observations noted but no real surprises. Upon conclusion of the inspection, the company received a handful of 483 observations. Again, nothing too significant. No major issues. Within a month or so, we were able address all the issues and successfully complete the observations.

Fast forward about 9 months later with the same client. Their ISO 13485 certification was due for renewal. The notified body came in for an audit. We believed we were prepared and ready. The recent FDA inspection gave us quite a bit of confidence. That confidence was quickly shot down. The auditor had a different style–much more passive aggressive. He also seemed to be proving a point, although I’m not exactly sure what the point was. The level of detail, the depth of documentation reviewed, the strong opinions were all very surprising to me. I have been on both sides of a QS audit many times throughout my career. While I acknowledge the client had plenty of shortcomings and opportunities for improvement, it really seemed this auditor was trying to make some kind of example. Upon the conclusion, we received nearly 20 findings and deficiencies. Some were relatively simple to address. Others would take months. And the company worked diligently to resolve and correct the issues. Within a couple months, we believed we were on the right path. And literally during the week that the ISO certification was to expire, the auditor had issues with many of our corrective actions. We were forced into firefighting mode. Sometimes it’s okay to fight fires. But this felt like we were catering solely to an auditors opinion and preferences. Eventually, all issues were addressed and recertification was issued.

I realize inspectors and auditors have opinions. I realize they see many, many ways to do things–some good, some not so good. And I realize the more the auditors like how you do things may make this process easier. But through these experiences, I found the FDA inspector was much more tolerant and open to different ways of doing things. The FDA inspector seemed more interested in the actual documentation and records rather than making too much fuss about the process. The notified body auditor was kind of the opposite. He was more concerned with the process and interjected his opinions and influence. Not that he didn’t care about the records, he just didn’t seem to put as much weight in them.

On a related note, I noticed that Rob Packard recently wrote a post “FDA Inspection Strategies that DON’T Work”. It’s a great read, especially for anyone preparing for FDA and/or notified body inspections.