# FDA 483 - UCSF Medical Center Clinical Laboratories Transfusion Service at Mission Bay - October 17, 2022

Source: https://www.keypedia.com/records/483/ucsf-medical-center-clinical-laboratories-transfusion-service-at-mission-bay/c0dc7753-7d17-48ae-aa32-66ec22184720

> FDA 483 for UCSF Medical Center Clinical Laboratories Transfusion Service at Mission Bay on October 17, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UCSF Medical Center Clinical Laboratories Transfusion Service at Mission Bay
- Inspection Date: 2022-10-17
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of UCSF Medical Center Clinical Laboratories Transfusion Service at Mission Bay in San Francisco revealed two significant observations. The facility failed to use supplies and reagents according to manufacturer instructions for antibody identification testing, a practice ongoing since 2014. Additionally, records for compatibility testing of blood and blood components were not concurrently maintained, making it difficult to trace all steps.

## Related Documents

- [483 - 2017-11-27](https://www.keypedia.com/records/483/ucsf-medical-center-clinical-laboratories-transfusion-service-at-mission-bay/eae30701-da30-4e19-b7b7-d03a41a2f4f0)

## Related Officers

- [Richard L. Bartlett](https://www.keypedia.com/people/richard-l-bartlett/602337b9-ac77-41bb-a254-71a9d345335b)

Company: https://www.keypedia.com/companies/ucsf-medical-center-clinical-laboratories-transfusion-service-at-mission-bay/08267cf9-4b42-4c4b-934e-864850827800

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b