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BRIEF-FDA performs pre-approval inspection of Intersect ENT's menlo park facility
November 6, 2017 / 1:16 PM / 12 days ago

BRIEF-FDA performs pre-approval inspection of Intersect ENT's menlo park facility

Nov 6 (Reuters) - Intersect ENT Inc

* FDA performs pre-approval inspection of Intersect ENT’s menlo park facility

* Intersect ENT Inc - ‍FDA has set a pdufa target action date of January 7, 2018​

* Intersect ENT Inc - ‍at conclusion of inspection, FDA issued a form 483 with four inspectional observations​

* Intersect ENT Inc - does not expect inspectional observations to impact timeline for a decision from FDA on approval of sinuva implant​ Source text for Eikon: Further company coverage:

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