Rate your FDA Audit Experience

[wynyards - 2008]

We are seeking FDA approval next year - whilst we think we understand what sytems we need in place we keep hearing horror stories about the actual FDA audits (and the Auditors)

What are they really like?

Any tips?

Should we just give up and go home?

 

[Al Rosen]

We are seeking FDA approval next year - whilst we think we understand what sytems we need in place we keep hearing horror stories about the actual FDA audits (and the Auditors)

What are they really like?

Any tips?

Should we just give up and go home?

We had an inspection in Feb 2003. The inspector was fair. He was familiar with our operation since he had previously performed inspections here . This was prior to my employment. In 2001, the then head of the CDRH, Dr Feigal, toured our facility with him.

I have heard the horror stories and I have been told by FDA inspectors that, "we are regulators". So, with that, my advice to you is to be prepared and organized. This will go a long way to a successful inspection.

Some tips:

1. Write an SOP for FDA Inspections(announced and unanounced). include what happens from the time the inspector walks through the door including who the receptionist notifies immediately and who will be involved in the inspection.
2. Follow the QSIT guidance document (attached) to prepare. Have an answer (documentation) for every box in the flow chart for every subsystem.
3. When the inspection occurs, assemble with the inspector(s) and everyone who will be involved in the inspection in a conference room. They will stay here most of the time while you retrieve records. Establish an area or room nearby this conference room to gather, review and make copies of the records and documentation. One copy for you and one copy for the inspector(s) prior to submitting them. BTW, this may include a copy of your Complaints database, that they will search and review (at their leisure when they leave) for MDR reportable events and "corrections and removals". They will be taking copies of everything you show them. So you will want to have a copy of the documents they take, for your records. See 21cfr 820.180c(), for records you are not required to give them.
4. ***During the inspection and plant tour, always have at least two people with the inspector so that someone can stay with them at all times and someone can retrieve documentation if necessary. Never let them roam freely.***
5. The inspector will discuss his observations and the items he will be noting on the 483. You should try to correct these if at all possible prior to the conclusion of the inspection. If that is not possible at least formulate a corrective action plan including completion dates.
6. After the inspection the person with executive responsibility should send a letter, describing the CA plan, to the FDA office.

Note, that if they believe they have to, they will extend the time for the inspection to gather more evidence..


If you prepare and at least appear organized, you will have no problem.

Good Luck!!

 

[keithm696 - 2008]

FDA Inspection

Hi,
I went thru an inspection (no notice) in August of 2003 and it wasn't fun but did learn alot about what we should be doing. We had processes in place but they were not in the level of detail that the inspector wanted to see. These couldn't be fixed before the inspection ended so we put together an action plan with completion dates. We also answered the 483 with this plan for those things that would require scheduled completions. It has been slow going because of reorginization that are internal but we are getting there.
Keith

 

[Al Rosen]

Inspection of Medical Device Manufacturers

I'm attaching the Manual that FDA Inspectors use for Audits. This is in addition to the QSIT Guidance previously posted. It offers some interesting insight as to what will be looked at and how often. According to it, CAPA is always audited along with at least one other major sub-system in the QSIT.

 

[Bubba]

Al,

Thanks for the attachments. We are getting ready for an FDA inspection next month and this is some valuable information for our preparations. Thanks again!

 

[Al Rosen]

This is an old thread, but I was wondering if anyone has had any recent experiences that they can add?

 

[MIREGMGR]

My understanding is that FDA is committed to beginning to wind down the broad-scale QSIT 1 inspection program for low- and some moderate-risk device makers within 2011, and to re-focusing their inspection force more heavily on inspections for cause and on higher-risk device makers, with some remaining attention to those companies that don't or can't take advantage of the new program.

They accepted voluntary submissions for the test of the Voluntary Audit Submission Program as of six months ago (i.e. submission of two years' ISO 13485 audit reports, with no major nonconformances allowed), and earlier this week announced that the VASP program would have staff prepared to evaluate its initial submissions starting in May or June.

They've already announced that submissions for a permanent program will begin around the end of 2011, so that doesn't leave them much room to decide that the pilot program didn't work.

As secondary evidence of this tectonic shift in FDA resource prioritization, the number of Warning Letters issued to device companies has been dropping for the past two years, and it's now to the point where it's become uncommon for the weekly Warning Letter report to have even one such warning letter for a device maker.

The company for which I work no longer regards readiness for a QSIT 1 inspection as a high priority. If it happens in the remaining months, so be it, but it seems less and less likely. Instead, our focus is on audits by our NB...particularly because a single major nonconformance could negatively affect our FDA relationship for two years.