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

Source: https://www.globalkeysolutions.net/records/483/spectrum-medical-ltd/8984c3da-4bb1-46ef-9b00-0471768b3a72

> FDA 483 for Spectrum Medical Ltd. on April 27, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spectrum Medical Ltd.
- Inspection Date: 2023-04-27
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2023-04-27](https://www.globalkeysolutions.net/records/warning_letter/spectrum-medical-ltd/4da02fc1-3044-473f-8235-75be531c5ef9)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/maida-henesian/cd28e878-000c-4af8-8dbd-4863057758bb)

Company: https://www.globalkeysolutions.net/companies/spectrum-medical-ltd/52c6d261-cfd9-438a-9ea6-9eb49f15ea02

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd