# FDA 483 - Lee Memorial Health System - August 06, 2021

Source: https://www.globalkeysolutions.net/records/483/lee-memorial-health-system/8b21ef3c-8411-4e1b-ba8f-942ebd44fcf8

> FDA 483 for Lee Memorial Health System on August 06, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lee Memorial Health System
- Inspection Date: 2021-08-06
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Lee Memorial Health System, a blood bank in Fort Myers, FL, was inspected and cited for multiple deficiencies related to donor notification and record-keeping. The inspection revealed failures in attempting to notify deferred donors, documenting notification attempts, and ensuring standard operating procedures adequately describe the notification process. Additionally, the firm failed to include required content in donor notification letters and did not consistently obtain valid contact addresses from donors.

## Related Officers

- [Doretha M Wilson](https://www.globalkeysolutions.net/people/doretha-m-wilson/85db7b75-2b34-4400-9c0d-9bde1235abf3)

Company: https://www.globalkeysolutions.net/companies/lee-memorial-health-system/e6bee5f0-2277-4e7f-a99e-2899dcdaf02a

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6