# FDA 483 - Health Park Medical Center - February 28, 2022

Source: https://www.globalkeysolutions.net/records/483/health-park-medical-center/44abe5b3-b7f9-470a-b14a-7f4ec56acbe0

> FDA 483 for Health Park Medical Center on February 28, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Health Park Medical Center
- Inspection Date: 2022-02-28
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Health Park Medical Center, a blood bank in Fort Myers, FL, was inspected by the FDA. The inspection revealed a significant failure to maintain adequate records for the investigation and follow-up of transfusion reactions. Specifically, no documentation of investigation and follow-up was found for 16 out of 16 reviewed transfusion reactions.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/health-park-medical-center/c3fd1da3-2568-4e1a-927c-56813fcef0b4

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