Mock FDA Inspection

FRA 2 FDA

Involved In Discussions
I have developed an inspection plan and have educated myself about what to expect in an inspection and dos and don'ts. But none of us has ever been through an FDA inspection before. I'd feel much better prepared if we could have someone knowledgeable about inspections come do a mini mock inspection. Nothing full-blown or formal, just a day of playing through what will happen, test running my plans and preparations, giving people practice answering questions during an inspection, etc. Any ideas where/how to find someone to do this? I unfortunately do not personally have any contacts in the FDA regulated world and I sure don't want to test run all of this during an actual inspection!
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Fda Qsit level one

They asked for capa, non conforming product control and management representation authority in the company. Basically can the MR stop a shipment of product out the door.

Whenever the auditor asked a question about a document or SOP we provided the purpose paragraph from the document. If they started digging we literally read the SOP verbatim. The auditor would listen but then he’d ask for another QMS document.

We repeated this process. Purpose paragraph, read SOP verbatim.

They wanted to see training records of anyone doing final inspections on product being shipped. Make sure those people have abilities documented in their job description and also their resume.

They asked for complaint data. Wanted to know a few example failures from investigation of complaints and any change notices about that specific issue.
 

ChrisM

Quite Involved in Discussions
My experience of FDA Inspections is that they are document inspections, not inspections of actual work taking place. They shut themselves in a a room and ask for documents and document registers. Make sure all your nonconformance reports and corrective action request forms are filled out correctly and dated chronologically with respect to expected dates of stages/actions. Make sure all training records are correct and up-to-date backed up with copies of external course certificates etc. Make sure your internal audit programme is up-to-date with audit report forms correctly filled out, appropriately signed and dated.

When the FDA Inspector asks to see a document, have someone check it before taking it to the inspector. Don't take any supporting or referenced info, wait for the inspector to ask for it. Good luck !
 

yodon

Leader
Super Moderator
Excellent points by all so far. Just a couple of things to add.

First, FDA inspectors don't have a hard timeline like ISO auditors do. They can stay as long as they feel they need (although the home office starts pressuring them to wrap things up after about 4 days if they stay that long). Whereas an ISO auditor may only request a couple of samples, an FDA inspector may want to see a greater number of samples.

If you have adverse events reported, they're likely to start there, pulling on every thread (timeliness, competency of personnel working the AE, reporting, follow-up, related doc control, etc.). If no AEs, they may go to complaints.

Historically, FDA has not (been allowed to ask for) management review, internal audit reports, and a few other things. With the adoption of 13485, those caveats seem to have been eliminated. I'll be curious if they start asking for these materials (I guess in theory they could start asking now).
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Excellent points by all so far. Just a couple of things to add.

First, FDA inspectors don't have a hard timeline like ISO auditors do. They can stay as long as they feel they need (although the home office starts pressuring them to wrap things up after about 4 days if they stay that long). Whereas an ISO auditor may only request a couple of samples, an FDA inspector may want to see a greater number of samples.

If you have adverse events reported, they're likely to start there, pulling on every thread (timeliness, competency of personnel working the AE, reporting, follow-up, related doc control, etc.). If no AEs, they may go to complaints.

Historically, FDA has not (been allowed to ask for) management review, internal audit reports, and a few other things. With the adoption of 13485, those caveats seem to have been eliminated. I'll be curious if they start asking for these materials (I guess in theory they could start asking now).
Ive told my senior management that although FDA can't see internal audits, they can see CAPA. Any serious internal audit findings probably are found in a CAPA log so in effect FDA sees all.
 

FRA 2 FDA

Involved In Discussions
I'm really more focused on the logistics, like a role-playing exercise.
  • When we are notified of an inspection, how do we communicate this to everyone?
  • How do we handle tracking document/record requests and communicate those to the right people
  • Conducting a tour of the facility
  • Who needs to be in the closing meeting
  • Give the scribe a chance to practice doing this job
  • A dress rehearsal for people to answer questions posed by an "inspector"
Like I said, I've written up a plan for this stuff and have some good pieces of advise to pass on to others in preparation but you can only plan something so effectively without ever actually running through it. And since none of us has experienced this, no one here can play inspector or even comment/improve on the plan. Maybe I'm going overboard, but I feel like I'd be walking into something important totally unprepared without having a practice run.
 

yodon

Leader
Super Moderator
You know what they say about plans - they're only good until you get punched in the mouth the first time. :)

For notifications, many have someone running up and down the halls screaming "the inspector is coming, the inspector is coming..." Kidding (somewhat). I think that depends on your organization. If small enough, an 'all hands' meeting.

Tracking docs: most companies have a "war room" (or "back office") where all requests are sent. They pull the documents & records, confirm they are suitable (as @ChrisM mentioned), log them, and deliver them.

Tour: that's going to be up to the inspector, but generally a walkthrough of each area, explaining what's done. Sometimes they want to go through the receiving > acceptance > storage > kitting > assembly ... processes in order.

Closing meeting: I think it's important to have someone from upper management there. Shows some level of commitment.

Where are you located? If I have any contacts in the area that might be good at acting as an inspector, I could see if they are interested.

Just keep calm. If your system is working reasonably well, the inspection should go fine. Unless there are egregious issues, the "worst" would be a 483 with findings that you can address.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Act calm. Others will look to you to set the tone.

We have a sop covering an fda audit. Do not guess at any answers. I’ll share wa redacted version in a pm
 

LUFAN

Quite Involved in Discussions
We are located in Vermont. Conveniently, it is a very pretty and popular time of year to visit... ;)
Rob Packard, founder of the Medical Device Academy is based in Vermont. I've used him for a few audits in the past including MDSAP for US/Canada. Not affiliated in any way but definitely recommended.

 
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