US Manufacturing Site Closing, device manufactured elsewhere

#1
Has anyone come across an instance where the legal manufacturer entity currently established and based in the US is shutting down. However the actual device itself is manufactured in Asia and the manufacturer wishes to continue manufacturing the device and selling it. I was wondering is this is a possible scenario? Also what would be the impact e.g if the FDA wanted to conduct an audit of the company?
 
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Ronen E

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#2
Short answer - Yes, it's possible, if certain measures are taken. Part of it would be stepping up and complying with all applicable legal-manufacturer-related regulations. That should get the manufacturer ready for FDA inspection anytime.

Long answer - Need to carefully work out the details according to specifics, prepare a work plan and take action. I'm sending you a PM.
 
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