Rashmi,
I do not understand what you mean by: '
additional non-conformities to be met through an email correspondence ' - did you reply to the investigator via email responding to the FDA Form 483 or did the investigator send your organisation additional non-conformities via email after the audit? I realise that both of these instances may be normal these days using technology and email, but both means are inappropriate.
First, asking for clarification from the investigator via email on Form 483 observations is fine, but that should have all been done at the closing meeting before the investigator left. You should formally respond to the Form 483 within 15 days to your local FDA office. Second, only non-conformities on Form 483 are observations via "official record" for the FDA. So if the investigator was sending additional information via email, this is a new one to me and is definitely not appropriate. (If that is the case, I would definitely get clarification from the local FDA office.)
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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 17-May-2018 07:51
From: Rashmi Pillay
Subject: FDA 483
Hi,
If the inspector has finished the audit, issued the 483s , however requires additional non-conformities to be met through an email correspondence , does it imply it's a 483 and should be actioned accordingly with the other 483s or should we respond to this requirement asap before the 483 responses to avoid one ?
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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