Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Hi,

During the FDA audit , if you know you are about to receive a 483 for not recording  complaints systematically , but if you have a procedure in place in currently(just before the audit) , can you convince the FDA to downgrade it to a deficiency by having the requirements completed before the audit / providing a timeline for completion of the same or can this be communicated only as a response to the 483 ?

​Hello,

My suggestion we be to document your remediation plan in a CAPA.  That could be your saving grace.  If you don't have a documented strategy in place that demonstrates that you have identified the systemic issue, determined the root cause, and initiated any corrective or preventative actions, the FDA will not accept it.  I wouldn't guarentee they would "downgrade" to a deficiency, however, it would be worth attempting.


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Adam Cargill RAC
Regulatory Affairs Manager
Warsaw IN
United States
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Original Message:
Sent: 10-May-2018 18:19
From: Anonymous Member
Subject: FDA audit -avoiding a 483

This message was posted by a user wishing to remain anonymous

​Hi,

During the FDA audit , if you know you are about to receive a 483 for not recording  complaints systematically , but if you have a procedure in place in currently(just before the audit) , can you convince the FDA to downgrade it to a deficiency by having the requirements completed before the audit / providing a timeline for completion of the same or can this be communicated only as a response to the 483 ?

It's always possible to influence an inspector's observations by providing additional information during the inspection, however based on your statements here, it sounds like a procedure is not the issue necessarily. It sounds more like a complaint management process has not been implemented/maintained or has not been implemented/maintained well in practice, so providing a new procedure at this stage will not likely change anything. The complaint records reviewed still indicate a problem, which cannot be undone. If this is the case, just use the new procedure as part of the response to the 483 and implement the new system effectively so that next time there's clear evidence of organization and control over complaints. 

Good luck,
Nathan

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Nathan Blazei
Director, Quality & Compliance
Durham NC
United States
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Original Message:
Sent: 10-May-2018 18:19
From: Anonymous Member
Subject: FDA audit -avoiding a 483

This message was posted by a user wishing to remain anonymous

​Hi,

During the FDA audit , if you know you are about to receive a 483 for not recording  complaints systematically , but if you have a procedure in place in currently(just before the audit) , can you convince the FDA to downgrade it to a deficiency by having the requirements completed before the audit / providing a timeline for completion of the same or can this be communicated only as a response to the 483 ?

FDA always assure the industries follow the regulations and stay in compliance at their highest level.

In your case FDA inspector already note down the complaint handling SOP was not adequate, its not like that, you don`t have it. You can always prepare draft for revised SOP and present that during inspection if you get a chance to do so.

The decision may vary based on criticality of the issue and view of the inspector. There is always positive impact on the agency when industries take the necessary, fruitful action promptly and show their willingness to reach to highest level of the compliance.



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Gaurang Bhavsar, MS, RAC
Manager, R&D and RA
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065
USA
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Original Message:
Sent: 10-May-2018 18:19
From: Anonymous Member
Subject: FDA audit -avoiding a 483

This message was posted by a user wishing to remain anonymous

​Hi,

During the FDA audit , if you know you are about to receive a 483 for not recording  complaints systematically , but if you have a procedure in place in currently(just before the audit) , can you convince the FDA to downgrade it to a deficiency by having the requirements completed before the audit / providing a timeline for completion of the same or can this be communicated only as a response to the 483 ?

It has been my experience that when an FDA inspector spends significant time on a certain aspect of an investigation, that area is going to be mentioned either on the EIR as an observation or listed on the 483.  If the inspector revisits the matter the next day, then it will most likely be on a 483.  As soon as possible, and before the close out meeting, argue your points on the matter, ensure that you understand that the FDA inspector feels you are not in compliance on the issue and provide a CAPA as record of attempting to comply.  With a CAPA in hand, the inspector would have a difficult time issuing a 483 point already in the process of correction, and would mention it in the EIR as an observation that warranted 483 but was/or is going to be corrected in short order.

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Robert Kozic
Somerset NJ
United States
------------------------------

Original Message:
Sent: 10-May-2018 18:19
From: Anonymous Member
Subject: FDA audit -avoiding a 483

This message was posted by a user wishing to remain anonymous

​Hi,

During the FDA audit , if you know you are about to receive a 483 for not recording  complaints systematically , but if you have a procedure in place in currently(just before the audit) , can you convince the FDA to downgrade it to a deficiency by having the requirements completed before the audit / providing a timeline for completion of the same or can this be communicated only as a response to the 483 ?