Arc Precision Acquisitions, LLC.March 20, 2024

FDA 483 - Arc Precision Acquisitions, LLC. - March 20, 2024

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Record Details

Arc Precision Acquisitions, LLC. in Isanti, MN, was inspected on March 20, 2024, and received one observation. The inspection revealed deficiencies in the firm's corrective and preventive action procedures. Specifically, the firm's CAPA procedure does not ensure that implemented corrective actions are validated or verified for effectiveness and to prevent adverse effects on finished devices.

Company: Arc Precision Acquisitions, LLC.
Inspection Date: March 20, 2024
Product Type: Device
Office: Minneapolis District Office
Person: Tyler R. Courtney (investigator)

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ID · 47804bc2-edbf-4378-a530-4c562548ab04