Regulatory Open Forum

One of the benefits of working in New Zealand over the US is scheduled FDA inspections - a refreshing change from the days of RED ALERT mode when the inspectors show up unannounced.  :)

However, I'm curious about the logistics...  If you're located OUS and have been subject to a recent FDA inspection - how long did it take to schedule an actual audit date from the time you were notified?  How much time between the date finalisation and the actual audit?  How many auditors and how many days? 

I've already reviewed the FDA materials for foreign manufacturer inspections, but want to know how things REALLY go down. Thanks in advance for any info!

I’ve assisted OUS clients with three OUS FDA routine inspections in the last year or so.  One was in your region (i.e., over in Sydney, Australia).  FDA will typically pre-announce the OUS inspection in writing (by email) approximately 3 months in advance of specific audit dates proposed by FDA.  You will usually be given 5 days within which to respond to FDA’s inquiry by giving FDA an inspection contact person and starting discussions about the proposed dates.

If you fail to respond within 5 days, FDA states that it will consider its regulatory options, including taking this into account in determining whether to sample or otherwise examine products from your facility when offered for import into the U.S. and in determining whether such products are subject to refusal of admission into U.S. commerce.

FDA expects that finalizing the inspection dates is a simple administrative act on your part, and I have always responded commensurately.  Specifically, I responded within the 5-day timeframe, and then had final agreement with FDA regarding the audit dates within a week or so thereafter.  If it takes a firm much longer than that to settle on the proposed audit dates, then the FDA will likely think the firm is being evasive.  Being evasive (or being viewed as evasive) is not a good way to start off any FDA inspection.

Typical OUS FDA inspections are what FDA calls “Level 2” inspections.  Level 2 inspections are “Comprehensive Inspections”, meaning that they will cover all four major subsystems (Management Controls, Design Controls, CAPA, and P&PC) (see the FDA’s QSIT Guide). FDA considers a Level 2 inspection to be a comprehensive review of the compliance status of the firm.

The Level 2 OUS “routine” inspections I’ve participated in were all 4 business days in duration for small to medium-sized firms.  They typically have one Investigator.  However, “for cause” inspections, other non-routine inspections, or larger firms could certainly dictate that the inspection go longer than 4 days, and involve more than one Investigator.

Hope this helps,

One of the benefits of working in New Zealand over the US is scheduled FDA inspections - a refreshing change from the days of RED ALERT mode when the inspectors show up unannounced.  :)

However, I'm curious about the logistics...  If you're located OUS and have been subject to a recent FDA inspection - how long did it take to schedule an actual audit date from the time you were notified?  How much time between the date finalisation and the actual audit?  How many auditors and how many days? 

I've already reviewed the FDA materials for foreign manufacturer inspections, but want to know how things REALLY go down. Thanks in advance for any info!

Thanks Kevin!  If it took longer than that (on the FDA's part), what do you think would be the cause - simple logistics or something related to review of the firm's data?

I’ve assisted OUS clients with three OUS FDA routine inspections in the last year or so.  One was in your region (i.e., over in Sydney, Australia).  FDA will typically pre-announce the OUS inspection in writing (by email) approximately 3 months in advance of specific audit dates proposed by FDA.  You will usually be given 5 days within which to respond to FDA’s inquiry by giving FDA an inspection contact person and starting discussions about the proposed dates.

If you fail to respond within 5 days, FDA states that it will consider its regulatory options, including taking this into account in determining whether to sample or otherwise examine products from your facility when offered for import into the U.S. and in determining whether such products are subject to refusal of admission into U.S. commerce.

FDA expects that finalizing the inspection dates is a simple administrative act on your part, and I have always responded commensurately.  Specifically, I responded within the 5-day timeframe, and then had final agreement with FDA regarding the audit dates within a week or so thereafter.  If it takes a firm much longer than that to settle on the proposed audit dates, then the FDA will likely think the firm is being evasive.  Being evasive (or being viewed as evasive) is not a good way to start off any FDA inspection.

Typical OUS FDA inspections are what FDA calls “Level 2” inspections.  Level 2 inspections are “Comprehensive Inspections”, meaning that they will cover all four major subsystems (Management Controls, Design Controls, CAPA, and P&PC) (see the FDA’s QSIT Guide). FDA considers a Level 2 inspection to be a comprehensive review of the compliance status of the firm.

The Level 2 OUS “routine” inspections I’ve participated in were all 4 business days in duration for small to medium-sized firms.  They typically have one Investigator.  However, “for cause” inspections, other non-routine inspections, or larger firms could certainly dictate that the inspection go longer than 4 days, and involve more than one Investigator.

Hope this helps,

One of the benefits of working in New Zealand over the US is scheduled FDA inspections - a refreshing change from the days of RED ALERT mode when the inspectors show up unannounced.  :)

However, I'm curious about the logistics...  If you're located OUS and have been subject to a recent FDA inspection - how long did it take to schedule an actual audit date from the time you were notified?  How much time between the date finalisation and the actual audit?  How many auditors and how many days? 

I've already reviewed the FDA materials for foreign manufacturer inspections, but want to know how things REALLY go down. Thanks in advance for any info!

I infer that by "longer than that”, you mean the 4-day duration.  Each scenario really needs to be considered carefully on its own merits to identify if there could be any triggers that might warrant longer than 4 days of inspection.  Firm size and past compliance history would be the key drivers for longer durations.

In any event, my experience has been that FDA is quite committed to maintaining its pre-arranged dates and audit durations.  The OUS inspections usually start on a Monday or Tuesday, and then end on Thursday or Friday.  FDA's own OUS logistics and schedules are very demanding.  I recall an OUS inspection where the inspector had to rush off to do another OUS inspection very soon thereafter in a different country.  Rescheduling or cancelling such arrangements would be very troublesome for all stakeholders.

In general scheduling seems to be very difficult for FDA with respect to OUS inspections.  For example, in the initial inquiry/notification, the FDA has typically asked right away for help with certain travel accommodations, to which we provided assistance.  But then later, literally within a few weeks before the inspection, I had frantic emails from an FDA “travel coordinator" who was still having trouble finding flights and hotel arrangements, even though the inspection was scheduled months earlier.  I think the FDA’s foreign inspection cadre is overtaxed and under-resourced.

I would say that an inspection originally scheduled for a 4-day duration would only go longer in the event of discovery of an extreme serious U.S. public health threat.  But even then, the routine inspection would probably end as scheduled, with the situation being quickly handed over from the FDA’s ORA DMPTI device inspections branch (handles routine OUS medical device inspections) to the Foreign Enforcement Branch of the Office of Compliance (handles OUS inspection enforcement actions when necessary) who would then expedite further actions as necessary.  For example, I had an OUS client recently go through a similar process where the routine ORA inspection ended on day 4 as planned, even though evidence/data was uncovered that ultimately led to a significant Warning Letter from the Office of Compliance.  (I wasn’t hired until after the Warning Letter).  Then the Warning Letter follow-up inspection was, you guessed it, 4 days in duration.  But every scenario can be different, so other Forum members may have additional examples to share that might have gone longer than 4 days.

Thanks Kevin!  If it took longer than that (on the FDA's part), what do you think would be the cause - simple logistics or something related to review of the firm's data?

I’ve assisted OUS clients with three OUS FDA routine inspections in the last year or so.  One was in your region (i.e., over in Sydney, Australia).  FDA will typically pre-announce the OUS inspection in writing (by email) approximately 3 months in advance of specific audit dates proposed by FDA.  You will usually be given 5 days within which to respond to FDA’s inquiry by giving FDA an inspection contact person and starting discussions about the proposed dates.

If you fail to respond within 5 days, FDA states that it will consider its regulatory options, including taking this into account in determining whether to sample or otherwise examine products from your facility when offered for import into the U.S. and in determining whether such products are subject to refusal of admission into U.S. commerce.

FDA expects that finalizing the inspection dates is a simple administrative act on your part, and I have always responded commensurately.  Specifically, I responded within the 5-day timeframe, and then had final agreement with FDA regarding the audit dates within a week or so thereafter.  If it takes a firm much longer than that to settle on the proposed audit dates, then the FDA will likely think the firm is being evasive.  Being evasive (or being viewed as evasive) is not a good way to start off any FDA inspection.

Typical OUS FDA inspections are what FDA calls “Level 2” inspections.  Level 2 inspections are “Comprehensive Inspections”, meaning that they will cover all four major subsystems (Management Controls, Design Controls, CAPA, and P&PC) (see the FDA’s QSIT Guide). FDA considers a Level 2 inspection to be a comprehensive review of the compliance status of the firm.

The Level 2 OUS “routine” inspections I’ve participated in were all 4 business days in duration for small to medium-sized firms.  They typically have one Investigator.  However, “for cause” inspections, other non-routine inspections, or larger firms could certainly dictate that the inspection go longer than 4 days, and involve more than one Investigator.

Hope this helps,

One of the benefits of working in New Zealand over the US is scheduled FDA inspections - a refreshing change from the days of RED ALERT mode when the inspectors show up unannounced.  :)

However, I'm curious about the logistics...  If you're located OUS and have been subject to a recent FDA inspection - how long did it take to schedule an actual audit date from the time you were notified?  How much time between the date finalisation and the actual audit?  How many auditors and how many days? 

I've already reviewed the FDA materials for foreign manufacturer inspections, but want to know how things REALLY go down. Thanks in advance for any info!

Actually I am more curious about the time to schedule the actual audit date.  Another NZ company had an experience in 2011 where it took 11 months after being notified of the inspection to actually settle on a date, which took place 9 weeks later.   However, I'm very happy with the other detail you provided - very helpful!

I infer that by "longer than that”, you mean the 4-day duration.  Each scenario really needs to be considered carefully on its own merits to identify if there could be any triggers that might warrant longer than 4 days of inspection.  Firm size and past compliance history would be the key drivers for longer durations.

In any event, my experience has been that FDA is quite committed to maintaining its pre-arranged dates and audit durations.  The OUS inspections usually start on a Monday or Tuesday, and then end on Thursday or Friday.  FDA's own OUS logistics and schedules are very demanding.  I recall an OUS inspection where the inspector had to rush off to do another OUS inspection very soon thereafter in a different country.  Rescheduling or cancelling such arrangements would be very troublesome for all stakeholders.

In general scheduling seems to be very difficult for FDA with respect to OUS inspections.  For example, in the initial inquiry/notification, the FDA has typically asked right away for help with certain travel accommodations, to which we provided assistance.  But then later, literally within a few weeks before the inspection, I had frantic emails from an FDA “travel coordinator" who was still having trouble finding flights and hotel arrangements, even though the inspection was scheduled months earlier.  I think the FDA’s foreign inspection cadre is overtaxed and under-resourced.

I would say that an inspection originally scheduled for a 4-day duration would only go longer in the event of discovery of an extreme serious U.S. public health threat.  But even then, the routine inspection would probably end as scheduled, with the situation being quickly handed over from the FDA’s ORA DMPTI device inspections branch (handles routine OUS medical device inspections) to the Foreign Enforcement Branch of the Office of Compliance (handles OUS inspection enforcement actions when necessary) who would then expedite further actions as necessary.  For example, I had an OUS client recently go through a similar process where the routine ORA inspection ended on day 4 as planned, even though evidence/data was uncovered that ultimately led to a significant Warning Letter from the Office of Compliance.  (I wasn’t hired until after the Warning Letter).  Then the Warning Letter follow-up inspection was, you guessed it, 4 days in duration.  But every scenario can be different, so other Forum members may have additional examples to share that might have gone longer than 4 days.

Thanks Kevin!  If it took longer than that (on the FDA's part), what do you think would be the cause - simple logistics or something related to review of the firm's data?

I’ve assisted OUS clients with three OUS FDA routine inspections in the last year or so.  One was in your region (i.e., over in Sydney, Australia).  FDA will typically pre-announce the OUS inspection in writing (by email) approximately 3 months in advance of specific audit dates proposed by FDA.  You will usually be given 5 days within which to respond to FDA’s inquiry by giving FDA an inspection contact person and starting discussions about the proposed dates.

If you fail to respond within 5 days, FDA states that it will consider its regulatory options, including taking this into account in determining whether to sample or otherwise examine products from your facility when offered for import into the U.S. and in determining whether such products are subject to refusal of admission into U.S. commerce.

FDA expects that finalizing the inspection dates is a simple administrative act on your part, and I have always responded commensurately.  Specifically, I responded within the 5-day timeframe, and then had final agreement with FDA regarding the audit dates within a week or so thereafter.  If it takes a firm much longer than that to settle on the proposed audit dates, then the FDA will likely think the firm is being evasive.  Being evasive (or being viewed as evasive) is not a good way to start off any FDA inspection.

Typical OUS FDA inspections are what FDA calls “Level 2” inspections.  Level 2 inspections are “Comprehensive Inspections”, meaning that they will cover all four major subsystems (Management Controls, Design Controls, CAPA, and P&PC) (see the FDA’s QSIT Guide). FDA considers a Level 2 inspection to be a comprehensive review of the compliance status of the firm.

The Level 2 OUS “routine” inspections I’ve participated in were all 4 business days in duration for small to medium-sized firms.  They typically have one Investigator.  However, “for cause” inspections, other non-routine inspections, or larger firms could certainly dictate that the inspection go longer than 4 days, and involve more than one Investigator.

Hope this helps,

One of the benefits of working in New Zealand over the US is scheduled FDA inspections - a refreshing change from the days of RED ALERT mode when the inspectors show up unannounced.  :)

However, I'm curious about the logistics...  If you're located OUS and have been subject to a recent FDA inspection - how long did it take to schedule an actual audit date from the time you were notified?  How much time between the date finalisation and the actual audit?  How many auditors and how many days? 

I've already reviewed the FDA materials for foreign manufacturer inspections, but want to know how things REALLY go down. Thanks in advance for any info!

Actually I am more curious about the time to schedule the actual audit date.  Another NZ company had an experience in 2011 where it took 11 months after being notified of the inspection to actually settle on a date, which took place 9 weeks later.   However, I'm very happy with the other detail you provided - very helpful!

Actually I am more curious about the time to schedule the actual audit date.  Another NZ company had an experience in 2011 where it took 11 months after being notified of the inspection to actually settle on a date, which took place 9 weeks later.   However, I'm very happy with the other detail you provided - very helpful!

I infer that by "longer than that”, you mean the 4-day duration.  Each scenario really needs to be considered carefully on its own merits to identify if there could be any triggers that might warrant longer than 4 days of inspection.  Firm size and past compliance history would be the key drivers for longer durations.

In any event, my experience has been that FDA is quite committed to maintaining its pre-arranged dates and audit durations.  The OUS inspections usually start on a Monday or Tuesday, and then end on Thursday or Friday.  FDA's own OUS logistics and schedules are very demanding.  I recall an OUS inspection where the inspector had to rush off to do another OUS inspection very soon thereafter in a different country.  Rescheduling or cancelling such arrangements would be very troublesome for all stakeholders.

In general scheduling seems to be very difficult for FDA with respect to OUS inspections.  For example, in the initial inquiry/notification, the FDA has typically asked right away for help with certain travel accommodations, to which we provided assistance.  But then later, literally within a few weeks before the inspection, I had frantic emails from an FDA “travel coordinator" who was still having trouble finding flights and hotel arrangements, even though the inspection was scheduled months earlier.  I think the FDA’s foreign inspection cadre is overtaxed and under-resourced.

I would say that an inspection originally scheduled for a 4-day duration would only go longer in the event of discovery of an extreme serious U.S. public health threat.  But even then, the routine inspection would probably end as scheduled, with the situation being quickly handed over from the FDA’s ORA DMPTI device inspections branch (handles routine OUS medical device inspections) to the Foreign Enforcement Branch of the Office of Compliance (handles OUS inspection enforcement actions when necessary) who would then expedite further actions as necessary.  For example, I had an OUS client recently go through a similar process where the routine ORA inspection ended on day 4 as planned, even though evidence/data was uncovered that ultimately led to a significant Warning Letter from the Office of Compliance.  (I wasn’t hired until after the Warning Letter).  Then the Warning Letter follow-up inspection was, you guessed it, 4 days in duration.  But every scenario can be different, so other Forum members may have additional examples to share that might have gone longer than 4 days.

Thanks Kevin!  If it took longer than that (on the FDA's part), what do you think would be the cause - simple logistics or something related to review of the firm's data?

I’ve assisted OUS clients with three OUS FDA routine inspections in the last year or so.  One was in your region (i.e., over in Sydney, Australia).  FDA will typically pre-announce the OUS inspection in writing (by email) approximately 3 months in advance of specific audit dates proposed by FDA.  You will usually be given 5 days within which to respond to FDA’s inquiry by giving FDA an inspection contact person and starting discussions about the proposed dates.

If you fail to respond within 5 days, FDA states that it will consider its regulatory options, including taking this into account in determining whether to sample or otherwise examine products from your facility when offered for import into the U.S. and in determining whether such products are subject to refusal of admission into U.S. commerce.

FDA expects that finalizing the inspection dates is a simple administrative act on your part, and I have always responded commensurately.  Specifically, I responded within the 5-day timeframe, and then had final agreement with FDA regarding the audit dates within a week or so thereafter.  If it takes a firm much longer than that to settle on the proposed audit dates, then the FDA will likely think the firm is being evasive.  Being evasive (or being viewed as evasive) is not a good way to start off any FDA inspection.

Typical OUS FDA inspections are what FDA calls “Level 2” inspections.  Level 2 inspections are “Comprehensive Inspections”, meaning that they will cover all four major subsystems (Management Controls, Design Controls, CAPA, and P&PC) (see the FDA’s QSIT Guide). FDA considers a Level 2 inspection to be a comprehensive review of the compliance status of the firm.

The Level 2 OUS “routine” inspections I’ve participated in were all 4 business days in duration for small to medium-sized firms.  They typically have one Investigator.  However, “for cause” inspections, other non-routine inspections, or larger firms could certainly dictate that the inspection go longer than 4 days, and involve more than one Investigator.

Hope this helps,

One of the benefits of working in New Zealand over the US is scheduled FDA inspections - a refreshing change from the days of RED ALERT mode when the inspectors show up unannounced.  :)

However, I'm curious about the logistics...  If you're located OUS and have been subject to a recent FDA inspection - how long did it take to schedule an actual audit date from the time you were notified?  How much time between the date finalisation and the actual audit?  How many auditors and how many days? 

I've already reviewed the FDA materials for foreign manufacturer inspections, but want to know how things REALLY go down. Thanks in advance for any info!

I infer that by "longer than that”, you mean the 4-day duration.  Each scenario really needs to be considered carefully on its own merits to identify if there could be any triggers that might warrant longer than 4 days of inspection.  Firm size and past compliance history would be the key drivers for longer durations.

In any event, my experience has been that FDA is quite committed to maintaining its pre-arranged dates and audit durations.  The OUS inspections usually start on a Monday or Tuesday, and then end on Thursday or Friday.  FDA's own OUS logistics and schedules are very demanding.  I recall an OUS inspection where the inspector had to rush off to do another OUS inspection very soon thereafter in a different country.  Rescheduling or cancelling such arrangements would be very troublesome for all stakeholders.

In general scheduling seems to be very difficult for FDA with respect to OUS inspections.  For example, in the initial inquiry/notification, the FDA has typically asked right away for help with certain travel accommodations, to which we provided assistance.  But then later, literally within a few weeks before the inspection, I had frantic emails from an FDA “travel coordinator" who was still having trouble finding flights and hotel arrangements, even though the inspection was scheduled months earlier.  I think the FDA’s foreign inspection cadre is overtaxed and under-resourced.

I would say that an inspection originally scheduled for a 4-day duration would only go longer in the event of discovery of an extreme serious U.S. public health threat.  But even then, the routine inspection would probably end as scheduled, with the situation being quickly handed over from the FDA’s ORA DMPTI device inspections branch (handles routine OUS medical device inspections) to the Foreign Enforcement Branch of the Office of Compliance (handles OUS inspection enforcement actions when necessary) who would then expedite further actions as necessary.  For example, I had an OUS client recently go through a similar process where the routine ORA inspection ended on day 4 as planned, even though evidence/data was uncovered that ultimately led to a significant Warning Letter from the Office of Compliance.  (I wasn’t hired until after the Warning Letter).  Then the Warning Letter follow-up inspection was, you guessed it, 4 days in duration.  But every scenario can be different, so other Forum members may have additional examples to share that might have gone longer than 4 days.

Thanks Kevin!  If it took longer than that (on the FDA's part), what do you think would be the cause - simple logistics or something related to review of the firm's data?

I’ve assisted OUS clients with three OUS FDA routine inspections in the last year or so.  One was in your region (i.e., over in Sydney, Australia).  FDA will typically pre-announce the OUS inspection in writing (by email) approximately 3 months in advance of specific audit dates proposed by FDA.  You will usually be given 5 days within which to respond to FDA’s inquiry by giving FDA an inspection contact person and starting discussions about the proposed dates.

If you fail to respond within 5 days, FDA states that it will consider its regulatory options, including taking this into account in determining whether to sample or otherwise examine products from your facility when offered for import into the U.S. and in determining whether such products are subject to refusal of admission into U.S. commerce.

FDA expects that finalizing the inspection dates is a simple administrative act on your part, and I have always responded commensurately.  Specifically, I responded within the 5-day timeframe, and then had final agreement with FDA regarding the audit dates within a week or so thereafter.  If it takes a firm much longer than that to settle on the proposed audit dates, then the FDA will likely think the firm is being evasive.  Being evasive (or being viewed as evasive) is not a good way to start off any FDA inspection.

Typical OUS FDA inspections are what FDA calls “Level 2” inspections.  Level 2 inspections are “Comprehensive Inspections”, meaning that they will cover all four major subsystems (Management Controls, Design Controls, CAPA, and P&PC) (see the FDA’s QSIT Guide). FDA considers a Level 2 inspection to be a comprehensive review of the compliance status of the firm.

The Level 2 OUS “routine” inspections I’ve participated in were all 4 business days in duration for small to medium-sized firms.  They typically have one Investigator.  However, “for cause” inspections, other non-routine inspections, or larger firms could certainly dictate that the inspection go longer than 4 days, and involve more than one Investigator.

Hope this helps,

One of the benefits of working in New Zealand over the US is scheduled FDA inspections - a refreshing change from the days of RED ALERT mode when the inspectors show up unannounced.  :)

However, I'm curious about the logistics...  If you're located OUS and have been subject to a recent FDA inspection - how long did it take to schedule an actual audit date from the time you were notified?  How much time between the date finalisation and the actual audit?  How many auditors and how many days? 

I've already reviewed the FDA materials for foreign manufacturer inspections, but want to know how things REALLY go down. Thanks in advance for any info!

And though I gave my insights about OUS inspection duration based on actual experience in light of your inquiry about "how things REALLY go down", it's still important to always stay up to speed on FDA's written policies, such as those to which you referred (i.e., the FDA's materials for foreign manufacturers inspections).  For example, therein FDA states, "The time allotted for each inspection varies depending on the type and number of products to be covered. Inspections of firms producing less critical products may be assigned less time than those making more technically complex items."

One of the benefits of working in New Zealand over the US is scheduled FDA inspections - a refreshing change from the days of RED ALERT mode when the inspectors show up unannounced.  :)

However, I'm curious about the logistics...  If you're located OUS and have been subject to a recent FDA inspection - how long did it take to schedule an actual audit date from the time you were notified?  How much time between the date finalisation and the actual audit?  How many auditors and how many days? 

I've already reviewed the FDA materials for foreign manufacturer inspections, but want to know how things REALLY go down. Thanks in advance for any info!