# FDA 483 - Vitalant Reference and Transfusion Service - August 05, 2019

Source: https://www.keypedia.com/records/483/vitalant-reference-and-transfusion-service/16f6e778-b170-4707-87fb-676a32d88821

> FDA 483 for Vitalant Reference and Transfusion Service on August 05, 2019. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Vitalant Reference and Transfusion Service
- Inspection Date: 2019-08-05
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of UPMC Clinical Services, a Hospital Blood Bank in Pittsburgh, identified significant deficiencies in record-keeping practices. Observations included a failure to maintain complete records for emergency transfusions, specifically regarding physician signatures. Additionally, the firm's maintenance logs were found to be incomplete, lacking dates, management reviews, and technician initials, indicating a systemic issue with documentation accuracy and completeness.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/brandon-l-mariner/c1ff0e66-552d-466a-9b49-a083d0211c94)

Company: https://www.keypedia.com/companies/vitalant-reference-and-transfusion-service/1bc47b85-6833-4939-bd16-6dd050536dbf

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8