483
Aurora Healthcare US CorpAurora Healthcare US Corp – FDA 483, Feb 17, 2022
Record Details
An FDA inspection of Aurora Healthcare US Corp in Danvers, MA, a manufacturer of the Aurora Dedicated Breast MRI System, revealed multiple significant procedural deficiencies. Observations included inadequate procedures for supplier quality management, corrective and preventive actions, complaint handling, management review, and quality audits. One observation regarding supplier re-evaluation was a repeat finding, indicating a persistent lack of compliance.
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