Spectrum Medical Ltd.April 27, 2023

FDA 483 - Spectrum Medical Ltd. - April 27, 2023

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Record Details

An FDA inspection of Spectrum Medical Ltd. in Gloucester, United Kingdom, a manufacturer of Quantum Perfusion Systems, identified a significant issue regarding their quality system. The firm failed to adequately document the verification or validation of corrective and preventive actions (CAPAs). Specifically, four CAPAs were closed without proper documentation of their effectiveness or impact on finished devices.

Company: Spectrum Medical Ltd.
Inspection Date: April 27, 2023
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Maida Henesian (investigator)

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ID · 8984c3da-4bb1-46ef-9b00-0471768b3a72