FDA Inspection
Medical Home Health Options dba The Plasma SourceMedical Home Health Options dba The Plasma Source – FDA Inspection, Jul 12, 2016
Record Details
This FDA Inspection record concerns Medical Home Health Options dba The Plasma Source, with an inspection on July 12, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 12, 2016
- Product Type
- Biologics
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ID · 24bc0431-56ca-4609-afb2-182c796dd4e8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 980687
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
19- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 640.63(c)(3)Blood hemoglobin
- 21 CFR 640.63(c)(9)Transmissible blood disease
- 21 CFR 640.63(c)(5)Serum protein
- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 640.72(d)Donor reaction
- 21 CFR 640.65(b)(1)(i)Serological test
- 21 CFR 640.63(a)Determining donor suitability
- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 640.72(a)(3)Donor consent
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