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FDA Audit next week

D

Doug Tropf

Quite Involved in Discussions
#21
#21
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:
 
Elsmar Forum Sponsor
W

Weiner Dog

Med Device Consultant
#22
#22
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. :)
 
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