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    FDA Form 483s for EBR SYSTEMS INC, Philips Medical Systems, Norman Noble Inc, and Others – Device Inspections

    FDA Form 483s for EBR SYSTEMS INC, Philips Medical Systems, Norman Noble Inc, and Others – Device Inspections

    $69.00 USD
    $69.00 USD
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    Original Request: I am requesting the following five inspection-related documents in electronic PDF format under the Product Type: Devices. 1) Form 483 for the inspection of EBR SYSTEMS INC (FEI 3013596742), located in Sunnyvale, California, inspection ending on January 17, 2025, project area: Compliance: Devices. 2) Form 483 for the inspection of Philips Medical Systems (Cleveland) Inc (FEI 3018004899), located in Gainesville, Florida, inspection ending on January 16, 2025, project areas: Compliance: Devices, Radiation Control and Health Safety Act, Postmarket Assurance: Devices. 3) Form 483 for the inspection of Norman Noble Inc (FEI 3002755653), located in Highland Heights, Ohio, inspection ending on December 19, 2024, project area: Compliance: Devices. ETC
    Tags: MedTech, 483, 2025
    • 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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