We were advised by the FDA that they will be out next week to conduct an audit. I'll post on how it goes and any insights I gain on what they are focusing on.

We were advised by the FDA that they will be out next week to conduct an audit. I'll post on how it goes and any insights I gain on what they are focusing on.

Good luck next week, Doug! Please let us know how things go. :cfingers:

We were advised by the FDA that they will be out next week to conduct an audit. I'll post on how it goes and any insights I gain on what they are focusing on.

Good luck, I would make sure your CAPA system is upto speed.

We were advised by the FDA that they will be out next week to conduct an audit. I'll post on how it goes and any insights I gain on what they are focusing on.

Since when do they let you know they're coming?

In June, I came back from a vacation on a Monday to learn the FDA had come for an inspection the previous Friday. They were just interested at looking at one part of the business - finished pharmaceuticals - and told us someone else will be coming later this year to look at our APIs. That's the first time we've ever had advanced warning of an inspection in the 10+ years I've been here.

Everything went well - no FDA-483 issued. We've had some 'interesting' history with the FDA in the past, so this was a welcome result - especially to the owners.

I'll echo Aaron on his advice - a good CAPA system is golden. They'll look for holes in your validations also - especially cleaning validations.

Good luck next week, Doug.

...Since when do they let you know they're coming? ...



In a previous life, they gave us a 24-hour notice that someone would be arriving for an inspection. I'm not sure if there is a rhyme or reason to why sometimes they give notice and sometimes they don't....:confused:

In a previous life, they gave us a 24-hour notice that someone would be arriving for an inspection. I'm not sure if there is a rhyme or reason to why sometimes they give notice and sometimes they don't....:confused:

It may depend on the district office involved.

Information on Pre-announcement of Inspections can be found in the FDA's Guide to Inspections of Quality Systems.

I was aware that CAPA issues have been the items most cited in recent years and have spent alot of time and effort bringing our CAPA procedures up to speed. Our registrar was OK with our CAPA system, however I believe we could do a better job with our root cause analysis efforts.

I have also reviewed some recent 483s citing complaint handling - particularly as it applies to MDR procedures. As a contract sterilizer, we don't actually market the product, so my understanding is the MDR requirements of CFR 803 would not apply to our operation.

Thanks for the good luck wishes. This is our first FDA inspection in soon to be four years.

Good luck.
All my federal inspection visits (OSHA, FDA, EPA) have been surprise ones.
I hope you get a personable inspector.

http://elsmar.com/jpg/Audit-Proof.jpg

Doug, have you looked at Rate your FDA Audit Experience (http://elsmar.com/Forums/showthread.php?t=9057). and the QUALITY SYSTEM MANUAL for Factory Inspections. (http://www.fda.gov/cdrh/qsr/18inspn.html)

Thanks Al, I reviewed the material you referenced. The Factory Inspection guide was a new one to me.

Good Luck to you.

Another reference would be - http://www.fda.gov/ora/cpgm/default.htm#devices

Information on Pre-announcement of Inspections can be found in the FDA's Guide to Inspections of Quality Systems.

I have also reviewed some recent 483s citing complaint handling - particularly as it applies to MDR procedures. As a contract sterilizer, we don't actually market the product, so my understanding is the MDR requirements of CFR 803 would not apply to our operation.

Thanks for the good luck wishes. This is our first FDA inspection in soon to be four years.

I believe you still have to have a MDR procedure...

I moved the post to this specific forum to get more responses.

Day one of our ongoing FDA audit went as follows:

Opening meeting
Tour of facility
Review of process deviations for past year plus related corrective actions
Review of customer contracts
CAPA - forms, procedures, open and closed CAPAs for past two years

Inspectors advised at the end of day one that they had not found anything that they were concerned about. :)

Day one of our ongoing FDA audit went as follows: .......................... Inspectors advised at the end of day one that they had not found anything that they were concerned about. :)

Great Job Doug :applause:

Appreciate that you took your valuable time off to update us. :thanx:

How many more days is the inspection ?

During day two the FDA inspectors audited:

Alarm testing and maintenance records on our process equipment
Calibrations of our monitoring and process equipment
Random samples of our DHRs
Job descriptions

So far - so good.

The following items were covered during day three of our inspection:

Sterilization cycle validations - including protocols
Steam quality testing
Process software applications and validations
Training procedures and documentation
Internal audit procedures and audit schedule
Management review procedures and evidence of meetings being held
Document control procedures
Process equipment calibrations / documentation

Wrap up is tomorrow, barring something unforeseen, I think we are good.:cfingers:

:applause::applause::applause:

Excellent job.

To add to your reference library is this link Investigations Operations Manual 2007 http://www.fda.gov/ora/inspect%5Fref/iom/, in the past it is updated
in March.
for medical device companies Chapter 5 is the ground rules for the Auditor.

I am not sure if one should be overly concerned about this, but it appears that for your Internal Audit program and Managment Review, you provided quite a bit of information.

Under 21 CFR 820.180(c) - (c) Exceptions. This section does not apply to the reports required by 820.20(c) Management review, 820.22 Quality audits, and supplier audit reports used to meet the requirements of 820.50(a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.

So basically when this subject matter comes out you have a upper management type to sign certifying that this activities are done.

Plus, it has been my experience that the Internal Audits being done and some outputs of Managment review show up in the CAPA system.

Still not sure if this is a point of concern . Your way of handling it should have been less adversarial, then some of the encounters I have witnessed for these sections of 21 CFR 820.

We did not present our actual internal audit or management review minutes for audit - only the written procedures for both and evidence (meeting announcements, audit schedules, etc) that these were being conducted.

One lesson learned - we had attached a copy of an internal audit report to one of our CAPAs (as a reference document) so in presenting our CAPA files for audit, we unintentionally presented an internal audit finding.

All in all the audit went well, the only surprise was that there was not alot of focus on some of the hot button items (according to trade publications, articles, etc) such as CAPA, root cause analysis and complaint handling.

Thanks to all that offered reference documents, guidance and well wishes.:thanx:

Hi. I worked as an FDA investigator (Level II Certified International Medical Device Investigator) for over 21 years- primarily in the medical device arena. Currently, I am a contract international medical device consultant for hire.

I want to comment about FDA inspections in general.

For medical devices, there are 3 types of inspections:
1. Pre-post 510(k)/PMA approval inspections.
2. Level I/II QSIT inspections.
3. Level III QSR compliance/for-cause inspections.

Since QSIT came about, FDA routinely informs US medical device firms (and only medical device firms, not firms that manufacture medical devices with other FDA regulated products as well- such as dual pharmaceutical/device companies) prior to the inspectional visit (unless the inspection is a follow up to a violative compliance inspection or a for-cause inspection). However, this practice has been conducted for years by FDA HQ when planning foreign inspection trips for the FDA investigators/CDRH staff. The reason why this came about for US sites, is to make sure that the firm is open and for the FDA investigator to obtain copies of high level written procedures for review prior to the visit (i.e. to save time during the inspection). The call is not to negotiate with FDA about an inspectional visit date. If the firm is open during the time stated by the FDA investigator, then the inspection will commence. If not, this could be deemed as an inspection refusal.

Additional details are contained in the QSIT manual and the medical device compliance program 7382.845 (both available on the FDA website).

i hope this information helps. :)