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Old 03-29-2020, 11:02 AM   #11
Gunkk
Thank you Al Oppenheiser!
 
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Many years ago I toured the Kokomo, IN (then AC Delco) electronics plant on a job interview. At the time it was mostly printed circuit board & component assembly with a chassis line for radios and other modules. The facility had a class 100 cleanroom.

Ventilators are class 2 medical devices. At the time, the facility, while a cleanroom, was not rated for medical device manufacturing. The Kokomo plant is not in the FDA establishment registration database, and GM does not operate any FDA licensed medical device manufacturing facilities.

The good news however, is that being a cleanroom, the site will likely already be ~90% complaint with environmental and pest controls. To get it completely rated for class 2 medical device manufacturing, GM will need a team of at least a dozen FDA inspectors helping to establish (not auditing) and execute the ISO13485 validation plan. That alone will take at least a week just to document everything correctly. There is no "waiver" authority for the President or anyone else for this requirement in the current US CFR, and none of the recent bills passed by congress allow it either.

Assuming that 1) the Ventec process is well documented which it likely is, and more important 2) GM has sourced 100% of the components and this is a huge assumption, it will take about 2 weeks to execute the training and validation plans from "go" which I am guessing was about 3 days ago.

I would expect the first Kokomo produced ventilator delivery by 9-April best case.
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