Is anyone out there considering using a Third-Party for their FDA Audit?

[Pataha]

Is anyone out there considering using a Third-Party for their FDA Audit?

[Al Rosen]

Originally Posted by patahaconsulting

Is anyone out there considering using a Third-Party for their FDA Audit?

I guess not. I know we aren't.

[Pataha]

Guess, I will have to think of another question. We decided not to go this route either.

The FDA visits us for free.

I was just looking for a reason to combine the FDA audit with the ISO Audit.

[Al Rosen]

Originally Posted by patahaconsulting

Guess, I will have to think of another question. We decided not to go this route either.

The FDA visits us for free.

I was just looking for a reason to combine the FDA audit with the ISO Audit.

The FDA is behind in their inspections. Why invite them in?

[Pataha]

Good question. Why would you invite an ISO Auditor in? Do people know when their next FDA Audit is up on the computer?

Is not the FDA and the Medical Device manufacturer utimately after the same things?

Since the 21 CFRs are the yard stick that I and my program is measured, how do I know how I am doing if I do not have them come and "peal the onion?'

Of course I am only a Class I and Class II device manufacturer and am not that sexy.
Plus, FDA Audits are on my Calendar and To Do list.

[Weiner Dog]

I was a level II certified medical device investigator & worked for the FDA for over 21 years. While at FDA, a district compliance officer (now retired) informed me if any firm uses an ex-FDA level II certified medical device investigator to conduct internal audits, that these internal audits count as FDA inspections. However, I have not been able to substanciate this claim since leaving FDA. Any comments?

[Doug Tropf]

Originally Posted by geochaz

I was a level II certified medical device investigator & worked for the FDA for over 21 years. While at FDA, a district compliance officer (now retired) informed me if any firm uses an ex-FDA level II certified medical device investigator to conduct internal audits, that these internal audits count as FDA inspections. However, I have not been able to substanciate this claim since leaving FDA. Any comments?

I have not heard of or come across any trade literature that would substantiate the officer's claim as being "official" FDA policy.

[MIREGMGR]

Geochaz, why don't you call DSMICA as if you're with a device manufacturer, and ask?

It's an interesting question. Obviously in your case it also would have interesting employability ramifications. I assume there are major medical-device companies that would like to have that capability in-house...particularly if, for instance, they're attempting to "recover" from an FDA regulatory marketing shutdown.

Note by the way that the regular-ISO-audits-will-be-accepted-as-FDA-Level-I-inspections plan is (supposedly) still in the works...most recently, for around the end of the year.