FDA Inspection
Memorial Hospital of South BendMemorial Hospital of South Bend – FDA Inspection, Nov 4, 2008
Record Details
This FDA Inspection record concerns Memorial Hospital of South Bend, with an inspection on November 4, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 4, 2008
- Product Type
- Biologics
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ID · 62fcdcb2-b614-4467-98ea-e3c40652f618
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 545821
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.151(e)Procedures to maintain records of emergency transfusions
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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