How soon do you get EIR after the FDA Inspection is done?

Elsmar Forum Sponsor
A

ascherp

#2
Re: How soon do you get EIR after inspection ?

Whenever the FDA is satisfied that the violations have been corrected or "appear to be adequate," as the Agency will write in their final response. The exact length of time basically depends on how long it took for someone at the Center to review the evidence and make a decision. A few months, sometimes a year or longer...
 
A

ascherp

#4
Probably since no 483 was issued, they considered you very low-risk and put you at the bottom of their pile of inspections to be followed up on.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#6
I was inspected not long ago. Closing meeting was May 6, total inspection was 2 days, one inspector (class I device). One 483 observation.
The EIR was postmarked 5/28.

I suspect a longer or more in-depth inspection would take longer to generate the report.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#7
We had one 483. Is it okay to check with FDA if the EIR is ready or we just wait ?
Just wait... unless it is coming up on the the time you commited to resolve the 483, in which case I might send the inspector a message asking the status.
 

sreenu927

Quite Involved in Discussions
#8
Hi Sgquality,

If you got a 483, then have you sent the response within 15 days with all objective evidence?
If yes, then the centre may take time to review, once satisfied, may take 1-2 months.

As all mentioned above, it all depends on your 483 response.

Regards,
Sreenu
 
B

BCBkWrm

#9
If you are simply describing when you will get the auditor's Inspection report, I believe they have 90 days to complete the report and send it to you. Correspondence regarding issuance of a warning letter or response to 483s is an entirely different issue as I understand it.
 

sreenu927

Quite Involved in Discussions
#10
In the inspection report, the actions indicated (Voluntary Action Indicated-VAI or Official Action Indicated -OAI) will be based on the 483 response submitted.
 
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