Compliance pains?
You are not alone.
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One third (1/3) of FDA inspections get 483's.
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FDA campus @ 10903 New Hampshire Ave., Silver Spring, MD
Compliance pains?
You are not alone.
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One third (1/3) of FDA inspections get 483's.
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One third (1/3) of inspections result in voluntary or official action. With no signs of improvement, this ratio has stayed steady between 30% and 40%, even though the number of inspections went up and down.
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Keeping abreast of FDA matters, I found clues of this compliance crisis in a file of FDA inspection results. So, I updated this website to do something about it. To recruit 100 experts with their opinions to find root causes and move towards solutions.
My plan is to interview 100 or so medical device quality managers and/or CEO’s and get individual opinions on the situation. This is an industry-wide problem. But, more importantly, it’s painful for individual medical device companies and leaders. You bear the burden of acknowledging and answering the citations and following through on your voluntary or official actions.
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FDA citations give clues to the infractions. But, the ‘why’ is missing. I know because I have read them. So, I will be calling you and your peers in the industry. I want to acknowledge and understand your current troubles and priorities. And, if you have any ideas how they can be addressed. If anything relevant and coherent is found I will see if a disruptive solution is appropriate. And, maybe write another article for MDDI. I'll send you a copy if you give me your email. I have started interviewing in Michigan, by phone and using Skype with people in other states.
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INTERVIEW There is some chance that you may not be in the 100 expert medical device practitioners I call. So, if you don't want to be left out you can try to CONTACT ME HERE. If you want to make absolutely sure and accelerate the process, just click BOOK AN INTERVIEW HERE and grab a time slot. You will get an email reminder and so will I. |