FDA 483s for Vitrolife, Remel, Arnold Tuber, Soulaire, Beckman Coulter – Medical Devices Inspections Dec 2024–Feb 2025

Original Request: Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Medical Devices inspection of Vitrolife Inc., located at 6835 Flanders Dr Ste 500, San Diego, CA 92121-3927, United States, inspection ending 1/23/2025 (FEI 3002757762). The 483 (in electronic format) for the Medical Devices inspection of Remel Inc., located at 1 Thermo Fisher Way, Oakwood Village, OH 44146-6536, United States, inspection ending 2/3/2025 (FEI 1000515493). The 483 (in electronic format) for the Medical Devices inspection of Arnold Tuber Industries, LLC, located at 10 Centre Dr Ste 1, Orchard Park, NY 14127-2280, United States, inspection ending 2/20/2025 (FEI 3003988575). The 483 (in electronic format) for the Medical Devices inspection of Soulaire Corporation, located at 1934 14th St Unit A, Santa Monica, CA 90404-4605, United States, inspection ending 12/5/2024 (FEI 3031814196). The 483 (in electronic format) for the Medical Devices inspection of Beckman Coulter, Inc., located at 1000 Lake Hazeltine Dr, Chaska, MN 55318-1037, United States, inspection ending 12/13/2024 (FEI 2122870). - Thank you!
Tags: MedTech, 483, 2025