# FDA 483 - Kentucky Blood Center Inc - September 18, 2023

Source: https://www.keypedia.com/records/483/kentucky-blood-center-inc/5852aaf7-e268-4842-931e-afdfcb888bd6

> FDA 483 for Kentucky Blood Center Inc on September 18, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kentucky Blood Center Inc
- Inspection Date: 2023-09-18
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: Kentucky Blood Center Inc, a blood bank in Lexington, KY, was cited for an unacceptable method for requalifying deferred donors. The firm re-entered a donor who was previously HCV repeat reactive using only one anti-HCV screening test, contrary to FDA's requirement for two different, licensed tests. This lapse resulted in the distribution of red cell and plasma units from this improperly re-entered donor.

## Related Officers

- [Jennifer L. Sheehan](https://www.keypedia.com/people/jennifer-l-sheehan/a49c628d-6eba-4b52-bafc-70785b9ba75e)

Company: https://www.keypedia.com/companies/kentucky-blood-center-inc/1f73e75a-da2d-4a6e-95e9-6515d58def98

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22