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

Has nobody outside the USA been audited by the FDA? Or is it too much like tempting fate? Anonymous replies are OK:)

Simon

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.

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

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

Simon,

Probably, this article speaks of it - FDA falling down on device inspections, says GAO (http://www.in-pharmatechnologist.com/news/ng.asp?n=83251-fda-gao-medical-devices-inspections)

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.

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.

I think this article gives a good overview on the topic. Regards.

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

We do not get audited by the FDA, but as primary supplier to one of our customers who is new to the US market (also based in the UK) we have had FDA 'inspections'. Basically an audit but obviously they don't have direct regulatory powers over us.

they don't have direct regulatory powers over us.

Won't stop them preventing the sale of your product if they find major problems though


;)

My previous company, located in Ontario, had mutliple locations in the US that were inspected every other year (or every year when 483's were found). The non-US facility where I worked was only inspected every 5 years or so (1996, 2001, 2006)

I believe that FDA is planning on opening inspectional offices in Europe and Asia. (Something that I wish would have happened when I was still with the FDA...) As such, foreign inspectional visits should occur more often. However, I do not think that they will be visiting foreign sites with the same frequency as US sites... however, the pendulum is turning the other way now with a democratic president...

My old company, class I and II devices, was not audited for 20 years. Then within a period of 2 years we were audited twice in the US, twice in Canada and one 2 weeks audit in Germany and Brussels. I think that was a result of a class III submission.

At another company we did get audited regulary, every 2 years, in Mexico.