FDA Form 483 – Medical Device Inspections (4 Firms Listed – June 2024)

FDA Form 483 – Medical Device Inspections (4 Firms Listed – June 2024)

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Original Request: Please provide the FDA-483 documents pertaining to Medical Device Inspection Inspection, for the following 4 firms: PACKAGE SOLUTIONS LLC, 2131 Blount Rd, Pompano Beach, FL, United States, (FEI: 3006559549), inspection ending 6/18/2024; Polygon Medical, Inc., 18 Hillside Dr, Holliston, MA, United States, (FEI: 3014407293), inspection ending 4/25/2024; Prove Labs Inc., 174 Macdonough St, Brooklyn, NY, United States, ETC
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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