FDA Inspection
Otero County Hospital AssociationOtero County Hospital Association – FDA Inspection, Aug 25, 2009
Record Details
This FDA Inspection record concerns Otero County Hospital Association, with an inspection on August 25, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- August 25, 2009
- Product Type
- Biologics
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ID · c2bc4b8c-3854-414a-bf36-6e033ad552c9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 608984
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
6- 21 CFR 606.100(c)Record review prior to release
- 21 CFR 606.121(f)Labeling of blood products unsuitable for transfusion
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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