FDA Inspection
The Medical Center of AuroraThe Medical Center of Aurora – FDA Inspection, Sep 12, 2014
Record Details
This FDA Inspection record concerns The Medical Center of Aurora, with an inspection on September 12, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- The Medical Center of Aurora
- Inspection Date
- September 12, 2014
- Product Type
- Biologics
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ID · 15c4eda0-9802-4a10-8207-7bf407a8fb3e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 895364
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.121(f)Labeling of blood products unsuitable for transfusion
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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