483
Agiliti Health - EllisFDA 483 - Agiliti Health - Ellis - November 02, 2023
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Raye's Inc., a medical device manufacturer in Ellis, KS, was inspected by the FDA and received two observations. The firm failed to adequately establish procedures for finished device acceptance testing and for ensuring purchased products and services conform to specified requirements. These issues indicate deficiencies in their quality system.
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ID · f48776ea-410b-4cba-abb3-de559716c428