FDA Routine Inspection Pre-Anouncement - What will be checked?

J

jayquality

#1
We are a european manufacturer of a medical device, class I for FDA, class I for europe.
Exemt from premarket approval, not exemt from GMP.

We received the pre-announcement for a 4 day routine inspection.
We have only 12 employees.

How much of the 21CFR820 will be audited?
Am i correct assuming its a level II inspection?
Is it similar (scope and depth) to a ISO 13485 audit?

Under the MDD, only a few sections are mandatory to class I devices, the scope of the iso 13845 can be reduced.
What about the FDA?
I cant find a list that tells me what sections are not applicable for class I except design control which is applicable since the device contains software.

tx
 
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M

MIREGMGR

#2
Re: FDA routine inspection pre-anouncement, what will be checked?

We received the pre-announcement for a 4 day routine inspection. (...) How much of the 21CFR820 will be audited? Am i correct assuming its a level II inspection?
The process and inspection-scope for a "routine" inspection (i.e. not a For Cause inspection, and usually Level 1 rather than Level 2) is explained in the QSIT Manual, http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm.
 
J

jayquality

#3
Re: FDA routine inspection pre-anouncement, what will be checked?

I was hoping for it to be a level i but according to the fda website:

"All foreign inspections should be conducted using the QSIT Guide under the Level 2 strategy"

http :// www .fda .gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm244267.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED
 
Last edited by a moderator:
M

MIREGMGR

#4
Not being subject to foreign inspection, I hadn't picked up on that. Thanks for pointing it out.
 

pkost

Trusted Information Resource
#7
My last FDA audit was about 2 years ago; it involved a single inspector turning up for 4 days to essentially turn a 4 employee company inside out.

All applicable areas of 21CFR820 were looked at (how could they not be in that time). The scope was obviously similar to ISO13485 but considering that an ISO audit would be 1-2 days, it was more thorough; more records were examined, it was not cursory. Even with the time avaliable it was clear the FDA has areas where it is more diligent, I think every complaint and CAPA was examined.

If they find anything that concerns them they delve much deeper and keep going when a notified body would otherwise stop, I asked the inspector about this and he pointed out that the NB issues a non conformance what's done is done, the evidence has been found, you have your non conformance. From his perspective he had identified a breach in the law and was gathering evidence to present in a court case; the more evidence he could find the better his chances of a successful prosecution.

From a scheduling perspective, everyday was started at 9 and stopped at 5; he only finished early on the last day (around lunch time). Lunch was limited to sandwiches in the audit room and none of the audit snacks consumed except by me. He refused our our offer to take him out for an evening meal every night. I appreciate the need not to accept lavish lunches/meals, also appreciate that some auditees will use lunch as a method to reduce audit time, but I found the rules to border on rude.

Overall he was fair and reasonable, he was approachable and gave some pointers and advise. Despite my comments above we faired quite well and only received a couple of 483's on issues that were relatively minor, we had I think 30days to respond to these to the FDA office, we did this and from recollection didn't hear anything more.
 

chris1price

Trusted Information Resource
#8
That's a good summary, my last FDA inspection in UK was 3 years ago and followed much the same process, 1 inspector, 4 days. Take a good look through the QSIT guidance, it will give a good indication of what will be reviewed. They will be much more thorough than an ISO auditor, requesting at every record (every complaint, Non-conformance, CAPA, DHR, etc). They may not look at them all, but they are good at finding the errors.

If you get any 483s, answer them as completely as possible, make sure your CAPA looks at every associated event, not just the one referenced. Have a look at FDA warning letters, you will see what they don't like!
 
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