FDA Inspection
Ochsner Health System Blood BankOchsner Health System Blood Bank – FDA Inspection, May 4, 2018
Record Details
This FDA Inspection record concerns Ochsner Health System Blood Bank, with an inspection on May 4, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · a4328a95-5756-4d2d-b00f-2a874476db12
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1050930
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 600.15Blood & Blood Components
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.40(a)(1)Provide space for examination
- 21 CFR 606.171Biological product deviation report
- 21 CFR 640.25(b)Quality control
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
- 21 CFR 606.65(e)Following manufacturer's instructions
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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 |
| March 31, 2022 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic 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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