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    FDA 483s – iRhythm Technologies (FEI 3007208829 & 3021769057, ~7/31/2024) & Establishment Labs (Alajuela, Costa Rica, ~7/26/2024)

    FDA 483s – iRhythm Technologies (FEI 3007208829 & 3021769057, ~7/31/2024) & Establishment Labs (Alajuela, Costa Rica, ~7/26/2024)

    $89.00 USD
    $89.00 USD
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    Request Contents: FDA Form 483 reports issued to iRhythm Technologies Inc for two facilities, FEI numbers 3007208829 and 3021769057, with inspection dates on or around 7/31/24. FDA Form 483 report issued to Establishment Labs located in Alajuela, Costa Rica, with inspection dates on or around 7/26/24.
    • Status: Pending Fast-Track Request
    • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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