FDA Inspection
Ochsner Health System Blood BankOchsner Health System Blood Bank – FDA Inspection, Mar 31, 2022
Record Details
This FDA Inspection record concerns Ochsner Health System Blood Bank, with an inspection on March 31, 2022, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 31, 2022
- Product Type
- Biologics
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ID · fb54280a-e7e9-4a0b-b702-8eab44ed83c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1166736
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
FDA Citations
3- 21 CFR 606.40(a)(1)Provide space for examination
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Ochsner Health System Blood Bank
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 5, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 4, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 3, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 19, 2013 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 17, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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