Pre-Announced FDA 4 Day Inspection, Class 2 Devices, Contract Manufacturer

somashekar

Leader
Admin
Today, we here in India successfully completed a pre-announced 4 day FDA inspection, the first FDA visit to us in which I and my team have been involved..... Well, no 483's, when I say successful completion.
:agree::thanx:
 

Mark Meer

Trusted Information Resource
Congrats!

It has been speculated (and my experience certainly confirms) that the US FDA is particularly thorough when it comes to foreign establishments.

Curious: did you find the auditor was exercising unusual scrutiny (as compared with other quality audits? e.g. ISO 13485, other regulatory)?
 

ScottK

Not out of the crisis
Leader
Super Moderator
No 483's over a 4 day inspection is great.
:applause:

can you share with us what they spent the most time focusing on?
 
M

MIREGMGR

This was an ordinary QSIT 2 inspection?

Or were they reviewing you as an extension of a "for cause" or regulatory-submission inspection of your customer?
 

somashekar

Leader
Admin
It was a scheduled pre-announced QSIT inspection.
Being contract manufacturer, we were not up with design controls, however, the focus areas were the DHR reviews, the complaints handling, the non-conformance handling and the CAPA process. Good alignment with our USA principles was a key factor in our success. The general awareness and understanding as demonstrated by our engineers and staff built the confidence. Specific attention was also towards validation, and its validity on a ongoing basis. Purchasing process including the change control agreements were inspected. In all the areas the number of sampling was certainly more than what the ISO 13485 CB audits do. Our communication and timely response put the FDA inspector at ease and the pace was maintained..... Thanks
 

somashekar

Leader
Admin
Last week we here in India successfully completed a pre-announced 4 day FDA inspection in our second site, again the first FDA visit to us in this site, in which I and my team have been involved..... Well, no 483's, when I say successful completion.
 
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