FDA Inspection
Ascension Sacred Heart Hospital Transfusion ServiceAscension Sacred Heart Hospital Transfusion Service – FDA Inspection, Aug 24, 2018
Record Details
This FDA Inspection record concerns Ascension Sacred Heart Hospital Transfusion Service, with an inspection on August 24, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 24, 2018
- Product Type
- Biologics
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ID · 0261a8db-844a-48a1-b1b6-b9c0d00c000e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063423
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Ascension Sacred Heart Hospital Transfusion Service
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2025 | Not classified | Florida District Office | |
| November 4, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| March 22, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Ascension Sacred Heart Hospital Transfusion Service
- FDA Inspection 1278390 - 2025-07-15
- FDA Inspection 1190995 - 2022-11-04
- FDA Inspection 971799 - 2016-03-22
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