FDA compliance crisis still a threat.

Founder and CEO of Menlo Park Associates and Menlo Park Software

November 2017

< 1 min reading time

New FDA data continues to show an industry in crisis. One third (1/3) of all site inspections still get CAPAs that are voluntary or official actions. This holds true going back to 2009. See the chart below. Note the black line that holds steady as the number of inspections goes up and down. This percentage should be decreasing every year, heading for zero.

When I see bad numbers staying bad I suspect systemic flaws. So, I am starting a research campaign. I will be calling a select group of 100 industry practitioners to get their take on the problem and the pains it inflicts on them and their organizations.

You can jump ahead of the line and contact me directly to contribute your thoughts. Be prepared to take a quick 5 question problem survey. You can also volunteer for a deeper interview on where the industry should head. Feel free to reply to this post. Also, get more information and be proactive on my website www.menloparkassociates.com. I look forward the conversation we can have.

Rick

source: https://www.linkedin.com/groups/78665/78665-6341694706862292992

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Posted by Richard Bollinger

Asked on November 29, 2017 12:00 am

76 views

	Private answer Julie Omohundro Given the consistency over time, it seems likely that this is a viable business model for some companies, that there is no flaw in their systems, and that it is instead working exactly the way they want it to, with periodic 483s, warning letters, and consent decrees included. Marked as spam Report spam
	Private answer Ginger Cantor Worked for a manager once who told me if you don't get a Warning Letter every so often you are not taking enough risks. Marked as spam Report spam
	Private answer Wow, Ginger Cantor. I wonder how the group feels about that! Marked as spam Report spam
	Private answer Julie Omohundro Potentially a reasonable business strategy, if you can quantify the rewards to be realized with the additional risks, the costs associated with the warning lerisks, and determine that the one outweighs the other. Marked as spam Report spam
	Private answer Ginger Cantor Hi Joe Hage, I was not surprised she said it, but it is a different point of view. But I have worked with companies under scrutiny and it is not fun. Marked as spam Report spam
	Private answer Roger Cepeda, JD, MBA, RAC I wonder about the chart- is that simply all inspections combined? Within a single facility, I would expect the problems to go down as Richard states, but if you are combining all facilities, including, for example, first time QSITs after a first time internal audit, you'd expect those to be higher. Also, when a big company acquires a smaller one, there are often post-closing part 820 issues to be cleaned up as the acquired org is brought under the parent company's quality system. I have heard Ginger's story many times in the context of advertising/promo-related warning letters (not part 820 violations). Some folks feel they've left money on the table if the company never gets cited for anything. Marked as spam Report spam
	Private answer Richard Bollinger Ginger Cantor, did your ex-manager know that it was patients that were ultimately taking those risks? And, Julie O., I think the 'business model' is more about letting it happen more than making it happen. It may be that compliance is more of an information problem than a moral problem. Marked as spam Report spam
	Private answer Richard Bollinger Roger Cepeda, the data is for all FDA inspections. The current dataset is "Inspections_Classifications_from_10-1-2008_through_11-15-2017.xlsx". The FDA states that from now on this data will be updated monthly. It will always include data back to 10-1-2008. I would expect acquisitions to track the economy and not hold steady for 9 years. Also, it would seem odd to me for organizations, after spending so much for compliance, to skimp on the last few dollars given the consequences of falling short and non-compliance. Looking at the citations might be useful. I will try to find and update a chart I have for the top ten 820 issues and add it to my website. Marked as spam Report spam
	Private answer Robert Christensen Ginger, you are so correct, it is not fun. In my battle with FDA I was facing a corrupt regime Marked as spam Report spam
	Private answer Christopher Wood Companies put short term emphasis on managing FDA inspection, not on improving quality management system. If the outcome is positive, management perceives QMS as effective, when in fact the only thing effective is how inspection was managed. Inspections are very often snapshots, not comprehensive. Doubtful MDSAP will change the paradigm. Paid NB's will be vertex of a conflict of interest. Marked as spam Report spam
	Private answer Ginger Cantor I heartily disagree with your manager. One can be innovative and aggressive without acting in a manner that invites adverse regulatory scrutiny. Such scrutiny can be time-intensive and may damage the brand. And such adverse regulatory scrutiny frequently invites more adverse regulatory scrutiny. Marked as spam Report spam
	Private answer Ginger Cantor Richard Bollinger I agree. That is never my position.... And was not the philosophy of the company I was with at the time! I am about patient/user safety first. Marked as spam Report spam
	Private answer Roger Cepeda, JD, MBA, RAC I'll make a prediction about Richard's findings. For larger companies, it's like a 5-year pendulum. Let's say the QA/RA org is properly funded and inspections are going well. A new biz leader will see that as an opportunity to reduce headcount/funding in QA/RA and "monetize" the value of a good reputation with the FDA. New biz leader gets promoted and moves on. Then something bad happens, revenue drops, and QA/RA rebuilds. Then they get back into good shape and the process repeats. Marked as spam Report spam
	Private answer Chea Kunwon,ASQ-CQA, PPI A platform/consulting service was creating as a solution to these FDA Compliance issues: QUACOAPIT LLC. They are on LinkedIn, Facebook, Youtube, Twitter, and email is Inquiry@quacoapit.com. They are ready to help!! Marked as spam Report spam
	Private answer Richard Bollinger All, I have updated my website and added a page for compliance failure. It has a chart showing the top 10 Part 820 subparts in terms of frequency in citations in FY2016. It also includes example citation descriptions. I will update to FY2017, but the spreadsheet is fairly complex. It will take a while. But, the current chart is still useful. I don't think the new chart will be very different. Marked as spam Report spam
	Private answer Richard Bollinger Chea Kunwon,ASQ-CQA, PPI, your website is down for maintenance. But, I think it is too soon to jump to a solution, no matter how much enthusiasm you have for it. Marked as spam Report spam
	Private answer Chea Kunwon,ASQ-CQA, PPI Richard Bollinger ; Thank you sir for the response. yes, the website is undergoing changes. However, there is one way to find out if it is too soon to jump to solution. You or someone who has FDA issues can ask us for help and see our results. We pride our self on Hard Work and Results. Inquiry@quacoapit.com is the email for our services. Marked as spam Report spam
	Private answer A compliant company requires a consistent nudge, or even a push, from the RA people who know the regulations. Without our outspoken guidance our companies will continue to believe they are meeting requirements. Speak up! If you are not heard speak up again and again. Listen to the objections and help others to find value in meeting the regulations. Marked as spam Report spam
	Private answer Julie Omohundro Richard, no argument there. Perhaps I should have put IF in all caps ("IF you can quantify..."). Marked as spam Report spam
	Private answer Julie Omohundro Roger, yes, that's the cycle I've seen. Whether this can be considered a business model, depends on whether management recognizes and accepts it, or, as Richard puts its, just "lets it happen." Best guess is that both scenarios are commonly found in the industry. Also , good point about the pitfalls of "average." I'm wondering if foreign inspections were included in these data. Marked as spam Report spam
	Private answer Richard Bollinger I have updated the chart on my website for the Top 10 Part 820 Subparts in terms of frequency in citations to FY2017. The percentages are very near the same. Only a few rankings moved up or down. It occurs to me that a business model that puts compliance and safety at higher risk depends them being expensive. If compliance and safety come cheap and easy, deliver better quality, then there is no incentive to skimp. Why bother if real savings come naturally? Marked as spam Report spam
	Private answer Love to be involved Marked as spam Report spam
	Private answer Richard Bollinger Deb Simpson, I am looking to interview medical device OEMs and your recent position as Quality Manager would appear to qualify you. If you can represent that experience I invite you to to take my short industry survey. A link to it is on my website which can be reached on my LinkedIn profile. You can also find there a link to learn more about an interview and find a time we are both available. Marked as spam Report spam

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