FDA Inspection
HealthOne Swedish Medical Center Blood BankHealthOne Swedish Medical Center Blood Bank – FDA Inspection, Sep 22, 2014
Record Details
This FDA Inspection record concerns HealthOne Swedish Medical Center Blood Bank, with an inspection on September 22, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- September 22, 2014
- Product Type
- Biologics
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ID · afa5dcfe-a53b-4877-a199-65d7067d049b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 897356
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(b)(12)Criteria for suitability of reissue of returned blood
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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