FDA 483 - Central California Blood Center/ Clovis Donor Center - December 11, 2024
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The FDA inspected Central California Blood Center/ Clovis Donor Center in Clovis, CA, and issued a Form 483 with two observations. The inspection revealed deficiencies in providing adequate storage space for blood and blood components, leading to potential contamination risks. Additionally, the facility failed to ensure that phlebotomists consistently followed standard operating procedures for blood sample collection, specifically regarding the inversion of sample tubes.
- Inspection Date
- December 11, 2024
- Product Type
- Biologics
- Person
ID · 985280d7-da56-496e-b038-ce80ea2e3b8c