FDA Form 483s for Eye-Novation LLC, Acuity Surgical Devices LLC, and Sun Scientific Inc – Device Inspections

FDA Form 483s for Eye-Novation LLC, Acuity Surgical Devices LLC, and Sun Scientific Inc – Device Inspections

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Original Request: Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Medical Devices inspection of Eye-Novation, LLC, located at 14360 SE 47TH PL, BELLEVUE, WA 98006-3138, United States, inspection ending 6/17/2024 (FEI 3019482162). The 483 (in electronic format) for the Medical Devices inspection of Acuity Surgical Devices, LLC, located at 8710 N ROYAL LN, IRVING, TX, 75063-2539, United States, inspection ending 1/27/2025 (FEI 3010866843). The 483 (in electronic format) for the Medical Devices inspection of Sun Scientific Inc, located at 145 PALISADE ST, SUITE LL11, DOBBS FERRY, NY, 10522-1617, United States, inspection ending 12/17/2024 (FEI 3008773774).ETC
Tags: MedTech, 483, 2024
  • 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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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