# FDA 483 - Amanda Unit, Heart and Chest Hospital, NHS Trust - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/amanda-unit-heart-and-chest-hospital-nhs-trust/80454eae-5046-4c1c-9e6a-9cdc9010242a

> FDA 483 for Amanda Unit, Heart and Chest Hospital, NHS Trust on Unknown Date. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Amanda Unit, Heart and Chest Hospital, NHS Trust
- Product Type: other
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Amanda Unit, Heart and Chest Hospital, NHS Trust in Liverpool, United Kingdom, revealed significant deficiencies in the conduct of a clinical study and the maintenance of adequate records. Observations included failures to follow the investigational plan and protocol, such as improper spirometer use and missing blood samples, as well as inadequate documentation for study drug dispensing. These findings indicate a need for improved oversight and record-keeping practices in clinical trial conduct.

## Related Officers

- [PRINCIPAL CONSULTANT](https://www.globalkeysolutions.net/people/james-m-kewley/5d6cec2d-e858-4de9-83c7-9260da2f08f7)

Company: https://www.globalkeysolutions.net/companies/amanda-unit-heart-and-chest-hospital-nhs-trust/761042c7-14dd-4d74-bd89-9bc7f572251a

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