How often does the FDA inspect organisations outside of the USA?
I am just conducting a quick straw poll to find out how frequently manufacturers outside the USA (with ISO13485 certification) of class II medical devices are inspected by the FDA?
Re: How often does the FDA inspect organisations outside of the USA?
Since we are located in the USA, I don't have an answer to your OP. However, I have read several recent aritcles/newsclips on the FDA's
intentions to increase inspections of organizations outside the USA that
market devices here.
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Re: How often do the FDA inspect organisations outside of the USA?
Of the four or five facility inspections we have each year by the FDA, I would say that about 30% are non-US, although if you have high numbers of MDR's or any class 1 recalls then you can expect a visit somewhat sooner.
Of course this is during a Republican government in the US and FDA funding is usually reduced during these periods. With Senator Waxman still making noises about FDA effectiveness and an election coming up, who knows what the future will bring?
With their current budget restrictions I believe you are still very unlikely to get an unannounced inspection outside of the US.
Jimmy
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Thanks to Jimmy the Brit for your informative Post and/or Attachment!
Re: How often does the FDA inspect organisations outside of the USA?
Quote:
Originally Posted by s.parakos
I am just conducting a quick straw poll to find out how frequently manufacturers outside the USA (with ISO13485 certification) of class II medical devices are inspected by the FDA?
This says - Most of the manufacturers inspected by the FDA are in the US, where more than half the 10,600 establishments registered as manufacturing class II or III medical devices are located. Between fiscal year 2002 and fiscal year 2007, the GAO found, the FDA conducted an average of 1,494 and 247 foreign establishment inspections each year, suggesting that the FDA annually inspects around 27 per cent of registered US establishments that have reported manufacturing class II or III medical devices, and around 5 per cent of the corresponding foreign establishments.
Another highlight - FDA officials interviewed by the GAO estimated that the agency inspects foreign manufacturers of class II medical devices once every 27 years and class III manufacturers every six years. The GAO also identified "challenges" faced by the FDA in managing its foreign medical device inspection programme.
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Thanks to Ajit Basrur for your informative Post and/or Attachment!
Re: How often does the FDA inspect organisations outside of the USA?
Quote:
Originally Posted by s.parakos
I am just conducting a quick straw poll to find out how frequently manufacturers outside the USA (with ISO13485 certification) of class II medical devices are inspected by the FDA?
thanks
Simon
Hi Simon,
We are a class II medical device manufacturer (oncology) in UK, were audited 1999 and just recently by SGS who performed our 13485 and QSIT (on behalf of FDA under new scheme) I believe there was an FDA audit in 1994 as well but before my time.
Thanks to madannc for your informative Post and/or Attachment!
Re: How often does the FDA inspect organisations outside of the USA?
A company I worked for previously, (Part of Abbott Laboratories) based in the UK hadn't been audited by the FDA for 6 years before I was made redundant and as far as I'm aware still haven't (4 years later)
I have it on good authority though that there IS a team of FDA inspectors in the UK most of the time and I'm sure could easily 'pop in' if they felt there was sufficient justification
How often does the FDA inspect organisations outside of the USA?
Re: How often do the FDA inspect organisations outside of the USA?
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