# FDA 483 - Danville Regional Medical Center - April 25, 2019

Source: https://www.keypedia.com/records/483/danville-regional-medical-center/148d9f78-242f-4b34-b4ef-89038121daed

> FDA 483 for Danville Regional Medical Center on April 25, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Danville Regional Medical Center
- Inspection Date: 2019-04-25
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Danville Regional Medical Center, a blood collection facility in Danville, VA, was inspected by the FDA from April 23-25, 2019. The inspection revealed two significant issues related to donor screening procedures and the concurrent maintenance of blood collection records. These observations indicate deficiencies in ensuring donor health and maintaining accurate, traceable documentation for blood and blood components.

## Related Officers

- [investigator](https://www.keypedia.com/people/randy-l-clarida/aae3cc15-a908-4489-9299-7542370ad3cd)

Company: https://www.keypedia.com/companies/danville-regional-medical-center/de4b0616-bb72-4419-a44e-b429b49d02ad

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e