FDA Inspection
UF Health Shands Medical Laboratories Blood BankUF Health Shands Medical Laboratories Blood Bank – FDA Inspection, Jan 25, 2018
Record Details
This FDA Inspection record concerns UF Health Shands Medical Laboratories Blood Bank, with an inspection on January 25, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 25, 2018
- Product Type
- Biologics
- People
- Barbara T. Carmichael (FDA Associated Person)
- Valerie J. Grecek-Trinh (Issuing Officer)
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ID · 759a0d69-eb53-49d4-ab88-e6da512ac978
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039044
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
Other FDA inspections of UF Health Shands Medical Laboratories Blood Bank
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2025 | Not classified | Florida District Office | |
| April 5, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 25, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 23, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 11, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for UF Health Shands Medical Laboratories Blood Bank
- FDA Inspection 1280793 - 2025-08-18
- FDA Inspection 1202804 - 2023-04-05
- FDA Inspection 967913 - 2016-02-25
- FDA Inspection 888207 - 2014-07-23
- FDA Inspection 798187 - 2012-09-11
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