483
Agiliti Health Inc.Agiliti Health Inc. – FDA 483, Aug 27, 2019
Record Details
Zetta Medical Technologies, LLC, a medical device manufacturer and CT assembler, was inspected by the FDA, revealing two significant observations. The firm's risk analysis was found to be inadequate, specifically regarding the definition of acceptable risk thresholds. Additionally, procedures for receiving, reviewing, and evaluating complaints were not adequately established, lacking requirements for documenting unique device identifiers and evaluating medical device reporting.
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- Chicago District Office
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ID · 483af824-22db-474d-82d1-3ac9e3ca31a8
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