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Re: Shawzzzzzz post# 200575

Tuesday, 07/09/2019 4:29:33 PM

Tuesday, July 09, 2019 4:29:33 PM

Post# of 425922
Apples and oranges. You are first of all talking about a device, not a “drug” with almost no SAEs (i.e. Vascepa), and secondly a device that if manufactured deficiently would result in extreme morbidity.

As stated, FDA applies a risk-based approach to CGMP compliance surveillance.

Regards,
-MRC

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