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Recent FDA audit


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#1 GMO

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Posted 22 April 2016 - 12:24 PM

Just wanted to assure people that our recent FDA audit was super simple.  He concentrated mainly on factory controls and probably only spent 50% of the time other auditors do on site.  We had one observation on one site and none on the other.  So my months worrying about it were largely pointless.   :crying:

 

So good luck if you have your FDA audit soon and I hope you get the same auditor we did!


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#2 swanswal

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Posted 27 June 2016 - 06:06 AM

Was the auditor an older experienced type, or a 'younger' person?  Just wondering......


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#3 GMO

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Posted 27 June 2016 - 02:57 PM

He was older, experienced and very informal in comparison with UK auditors.


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#4 ChristinaG

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Posted 28 June 2016 - 03:15 PM

Please excuse my ignorance, but an auditor from the US FDA? 

 

I have seen reports that FSMA has placed a higher demand for FDA Auditors, so you may soon be experiencing audits conducted by younger auditors (which could be a good or bad thing, depending on who you ask). 

 

Does it work like a certification audit where you're given a score, or is it just a pass/fail kind of thing? (I'm in packaging, and the USFDA doesn't inspect packaging manufacturers, so I'm just curious)


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-Christina

 

"Imagination is more important than knowledge. For knowledge is limited, whereas imagination embraces the entire world, stimulating progress, giving birth to evolution."- Albert Einstein 


#5 ChristinaG

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Posted 28 June 2016 - 03:21 PM

Oh my gosh, I just realized what forum this was in, and of course it was the USFDA.

I'm just going to dig myself a hole to hide in.... :oops2:


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-Christina

 

"Imagination is more important than knowledge. For knowledge is limited, whereas imagination embraces the entire world, stimulating progress, giving birth to evolution."- Albert Einstein 


#6 Charles.C

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Posted 28 June 2016 - 03:53 PM

I may be wrong but it was probably an audit related to FSMA but presumably implemented in UK ??

 

Whether this defines the auditor himself as being from USFDA  I'm unsure ?? But definitely not of UK origin.

 

Over to  GMO.


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Kind Regards,

 

Charles.C


#7 GMO

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Posted 29 June 2016 - 07:09 AM

I may be wrong but it was probably an audit related to FSMA but presumably implemented in UK ??

 

Whether this defines the auditor himself as being from USFDA  I'm unsure ?? But definitely not of UK origin.

 

Over to  GMO.

 

Yes a US FDA auditor, conducting the audit in the UK.


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